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Effect of Lifestyle and/or Metformin Intervention on Pregnancy Outcome, A Pilot Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT03898037
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Reproductive & Genetic Hospital of CITIC-Xiangya

Tracking Information
First Submitted Date  ICMJE March 29, 2019
First Posted Date  ICMJE April 1, 2019
Last Update Posted Date September 25, 2020
Actual Study Start Date  ICMJE June 13, 2019
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
Ongoing Pregnancy Rate [ Time Frame: 8 months ]
Number of women with ongoing pregnancy / number of women randomized to the specific group. Ongoing pregnancy was defined as the presence of a fetus with heart motion at 10 to 12 weeks of gestation.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
  • Number of eggs obtained [ Time Frame: 5 months ]
    The total number of oocytes obtained after one treatment cycle
  • Biochemical Pregnancy Rate [ Time Frame: 5 months ]
    Number of women with Biochemical pregnancy /number of women randomized to the specific group. Biochemical pregnancy was defined as a human chorionic gonadotropin level of more than 10 milli-International unit(mIU)per milliliter(ml), as measured at about 14 days after embryo transfer.
  • Clinical Pregnancy Rate [ Time Frame: 6 months ]
    Number of women with clinical pregnancies /number of women randomized to the specific group. Clinical pregnancy was defined as the presence of a gestational sac in the uterine cavity at about 28 days after embryo transfer, as detected on ultrasonography.
  • Live birth rate [ Time Frame: 16 months ]
    Number of women with live births / number of women randomized to the specific group. Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation after our interventions.
  • Duration of pregnancy [ Time Frame: 16 months ]
    The time from the first day of last menstrual period to the day of delivery.
  • Birth weight [ Time Frame: 16 months ]
    Weight of newborns at delivery.
  • Pregnancy Loss Rate [ Time Frame: 12 months ]
    Number of pregnancy losses / number of clinical pregnancies. Pregnancy loss refers to a complete spontaneous abortion or a nonviable pregnancy before 28 weeks of gestation.
  • Incidence of moderate to severe ovarian hyperstimulation syndrome(OHSS) [ Time Frame: 6 months ]
    Number of cycles of moderate to severe OHSS/total number of fresh stimulation cycle.
  • Cumulative incidence of maternal and neonatal complications during whole gestation and prenatal stage [ Time Frame: 16 months ]
    Number of pregnancies with complications / number of pregnancies; Number of live births with neonatal complications / number of live births;
Original Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
  • Number of eggs obtained [ Time Frame: 5 months ]
    The total number of oocytes obtained after one treatment cycle
  • Biochemical Pregnancy Rate [ Time Frame: 5 months ]
    Number of women with Biochemical pregnancy /number of women randomized to the specific group. Biochemical pregnancy was defined as a human chorionic gonadotropin level of more than 10 mIU per milliliter, as measured at 14 about days after embryo transfer.
  • Clinical Pregnancy Rate [ Time Frame: 6 months ]
    Number of women with clinical pregnancies /number of women randomized to the specific group. Clinical pregnancy was defined as the presence of a gestational sac in the uterine cavity at about 28 days after embryo transfer, as detected on ultrasonography.
  • Live birth rate [ Time Frame: 16 months ]
    Number of women with live births / number of women randomized to the specific group. Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation after our interventions.
  • Duration of pregnancy [ Time Frame: 16 months ]
    The time from the first day of last menstrual period to the day of delivery.
  • Birth weight [ Time Frame: 16 months ]
    Weight of newborns at delivery.
  • Pregnancy Loss Rate [ Time Frame: 12 months ]
    Number of pregnancy losses / number of clinical pregnancies. Pregnancy loss refers to a complete spontaneous abortion or a nonviable pregnancy before 28 weeks of gestation.
  • Incidence of moderate to severe OHSS [ Time Frame: 6 months ]
    Number of cycles of moderate to severe OHSS/total number of fresh stimulation cycle.
  • Cumulative incidence of maternal and neonatal complications during whole gestation and prenatal stage [ Time Frame: 16 months ]
    Number of pregnancies with complications / number of pregnancies; Number of live births with neonatal complications / number of live births;
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Lifestyle and/or Metformin Intervention on Pregnancy Outcome, A Pilot Randomized Controlled Trial
Official Title  ICMJE Effect of Lifestyle and/or Metformin Intervention on Pregnancy Outcome in Overweight/Obese Non-pcos Infertility Women With Insulin Resistance , A Pilot Randomized Controlled Trial
Brief Summary The purpose of pilot trial is to compare the efficacy of lifestyle intervention, metformin intervention, lifestyle combined with metformin intervention in improving assisted reproductive technology in non-polycystic ovary syndrome(pcos) patients with overweight/obesity and insulin resistance compared with conventional clinical education. Subjects who meet the inclusion criteria will be randomized to four groups: lifestyle intervention group, metformin intervention group, lifestyle combined with metformin intervention group, and routine clinical education group. Subjects of above three intervention group will start ovulation stimulation treatment after reach the aim or duration of intervention and routine clinical education group has no intervention. All subjects are treated with the same procedures, including a long ovarian stimulation regimen, oocyte retrieval, and fertilization, followed by a planned transfer of two day-3 embryos. The primary outcome is ongoing pregnancy rate.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Infertility, Female
  • Obesity
  • Insulin Resistance
Intervention  ICMJE
  • Behavioral: weight loss intervention
    weight loss intervention under the guidance of a dietitian, including: restricted energy balanced diet, aerobic exercise, etc.
  • Drug: metformin intervention
    metformin intervention with a starting dose of 0.5g bid, and the dose will be adjusted by doctors according to the patient's insulin level and adverse events.
Study Arms  ICMJE
  • Experimental: lifestyle intervention group

    Subjects will receive weight loss intervention under the guidance of a dietitian after assigned to lifestyle intervention group, including: restricted energy balanced diet, aerobic exercise, etc. Subjects will come to the hospital to measure their height, weight, waist circumference, hip circumference, body fat rate, BMI and test oral glucose tolerance test (OGTT)/insulin resistance test(IRT)/HOMA, blood routine, liver and kidney function on the day of grouping and in the 4th week, the 8th week, the 12th week after grouping.

    The aim is to lose 5-10% of the initial body weight. If the target was reached within 3 months, subjects will receive ovarian stimulation treatment in advance, otherwise treatment starts after 3 months. All subjects are treated with the same procedures,including a long ovarian stimulation regimen, oocyte retrieval, and fertilization, followed by a planned transfer of two day-3 embryos. The pregnancy and perinatal outcomes after transfer were followed up.

    Intervention: Behavioral: weight loss intervention
  • Experimental: metformin intervention group

    Subjects will be given metformin intervention with a starting dose of 0.5g bid after assigned to metformin intervention group, and the dose will be adjusted by doctors according to the insulin level and adverse events. Subjects will come to the hospital to measure their height, weight, waist circumference, hip circumference, body fat rate, BMI and test OGTT/IRT/HOMA, blood routine, liver and kidney function on the day of grouping and the 4th week, the 8th week, the 12th week after grouping.

    The aim is to adjust insulin level to normal within 3 months. If the target was reached within 3 months, subjects will start to receive ovarian stimulation treatment in advance, Otherwise treatment starts after 3 months. All subjects are treated with the same procedures, including a long ovarian stimulation regimen, oocyte retrieval, and fertilization, followed by a planned transfer of two day-3 embryos etc. The pregnancy and perinatal outcomes after transfer were followed up.

    Intervention: Drug: metformin intervention
  • Experimental: lifestyle combined with metformin intervention group

    Subjects will receive weight loss intervention and metformin intervention after assigned to lifestyle combined with metformin intervention group. Subjects will come to the hospital to measure their height, weight, waist circumference, hip circumference, body fat rate, BMI and test OGTT/IRT/HOMA, blood routine, liver and kidney function on the day of grouping and in the 4th week, the 8th week, the 12th week after grouping.

    The aim is to lose 5-10% of the initial body weight and adjust insulin level to normal within 3 months. If the target was reached within 3 months, subjects will receive ovarian stimulation treatment in advance, otherwise treatment starts after 3 months. All subjects are treated with the same procedures,including a long ovarian stimulation regimen, oocyte retrieval, and fertilization, followed by a planned transfer of two day-3 embryos etc. The pregnancy and perinatal outcomes after transfer were followed up.

    Interventions:
    • Behavioral: weight loss intervention
    • Drug: metformin intervention
  • No Intervention: routine clinical education group
    Subjects will only accept clinical routine education after assigned to routine clinical education group. Subjects will measure their height, weight, waist circumference, hip circumference, body fat rate, BMI and test OGTT/IRT/HOMA, blood routine, liver and kidney function on the day of grouping and will start induced ovulation therapy after completing routine clinical examination. All subjects are treated with the same procedures,including a long ovarian stimulation regimen, oocyte retrieval, and fertilization, followed by a planned transfer of two day-3 embryos etc. The pregnancy and perinatal outcomes after transfer were followed up.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 29, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Women ages 18 to 36 years.
  2. Women BMI at least 25kg/m2.
  3. Women who are non-pcos patient(2003 Rotterdam criteria).
  4. Women with insulin resistance (HOMA criteria).
  5. Women who are participating in their first or second fresh embryo cycle of in- vitro fertilization(IVF) or intracytoplasmic sperm injection (ICSI).
  6. Women who are indicated IVF or ICSI.

Exclusion Criteria:

  1. Women with endometriosis.
  2. Women with untreated hydrosalpinx.
  3. Women with a uterine cavity abnormality, such as a uterine congenital malformation; untreated uterine septum(except shallow uterine septum), adenomyosis, submucous myoma, or intrauterine adhesions.
  4. Women who are indicated and planned to undergo preimplantation genetic diagnosis(PGD)/preimplantation genetic screening(PGS).
  5. Women with endocrine abnormalities, such as Cushing syndrome, congenital adrenal hyperplasia, pituitary amenorrhea, thyroid dysfunction etc.
  6. Women who had participated in other treatments known to affect diet or weight (such as diet drugs and dietitian intervention) for past 3 months.
  7. Women who are unable to follow verbal and written instructions.
  8. Women who use donated oocytes to achieve pregnancy.
  9. Women with poor ovarian response(Bologna criteria).
  10. Women with diabetes mellitus, abnormal glycosylated hemoglobin.
  11. Women who has a history of recurrent spontaneous abortion.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 36 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03898037
Other Study ID Numbers  ICMJE P2019001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Reproductive & Genetic Hospital of CITIC-Xiangya
Study Sponsor  ICMJE Reproductive & Genetic Hospital of CITIC-Xiangya
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Reproductive & Genetic Hospital of CITIC-Xiangya
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP