Trial record 2 of 63 for:    Polycystic Ovary Syndrome: Clinical Trials

Live Birth After Fresh Embryo Transfer Vs Frozen-thawed Embryo Transfer in Women With Polycystic Ovary Syndrome (FreFro-PCOS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Jiangsu Province Hospital
Sixth Affiliated Hospital, Sun Yat-sen University
Anhui Medical University
RenJi Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
LanZhou University
Guangxi provincial maternal and chidren's hospital
Renmin Hospital of Wuhan University
Yuhuangding Hospital of Yantai
Jiangxi Maternal and Child Health Hospital
Sir Run Run Shaw Hospital
Shanxi Provincial Maternity and Children's Hospital
Reproductive Medicine Center in Shenyang City
Information provided by (Responsible Party):
Zi-jiang Chen, Shandong University
ClinicalTrials.gov Identifier:
NCT01841528
First received: April 18, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women of childbearing age. However, the optimal infertility treatment for PCOS patients is still a matter of controversy. Despite producing more follicles and more oocytes than other women undergoing controlled ovarian hyperstimulation during an IVF cycle, women with PCOS have comparable or lower pregnancy rates. Additionally women with PCOS patients undergoing IVF have a higher risk of developing ovarian hyperstimulation syndrome (OHSS), which may be aggravated by pregnancy after an embryo transfer in a fresh cycle. Further women with PCOS are thought to have higher rates of later pregnancy complications including spontaneous abortion, pre-eclampsia, and preterm labor that may be related to impaired implantation in the superovulated endometrium. We propose a randomized clinical trial of elective embryo cryopreservation followed by a programmed cycle of endometrial preparation and frozen embryo transfer (FET) compared to fresh embryo transfer in women with PCOS undergoing in vitro fertilization (IVF).


Condition Intervention
Polycystic Ovary Syndrome
Infertility
Other: fresh embryo transfer
Other: frozen-thawed embryo transfer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Live Birth After Fresh Embryo Transfer vs Elective Embryo Cryopreservation/Frozen Embryo Transfer in Women With Polycystic Ovary Syndrome Undergoing IVF: A Multi-center Prospective Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Shandong University:

Primary Outcome Measures:
  • live birth rate [ Time Frame: 10 months for group A, 12 months for group B ] [ Designated as safety issue: No ]
    This will be based on the outcome of either the fresh embryo transfer after ovarian stimulation (Group A) or the outcome of the first frozen embryo transfer cycle (Group B) as will all other secondary outcomes.


Secondary Outcome Measures:
  • Ovarian hyperstimulation syndrome (OHSS) incidence [ Time Frame: 2 months in maximum estimated ] [ Designated as safety issue: Yes ]
  • clinical pregnancy rate [ Time Frame: 35 days after embryo transfer ] [ Designated as safety issue: No ]
    This will be based on the visualization of a intrauterine gestational sac by ultrasound.

  • Pregnancy Loss rate [ Time Frame: 28 weeks gestation in maximum ] [ Designated as safety issue: Yes ]
    Loss of pregnancy will be defined by any positive pregnancy test that does not result in a live birth and will be tracked.

  • ectopic pregnancy rate [ Time Frame: 7~8 weeks gestation ] [ Designated as safety issue: Yes ]
  • singleton live birth rate [ Time Frame: 10 months for group A, 12 months for group B ] [ Designated as safety issue: No ]
  • pregnancy complication rate [ Time Frame: 10 months for group A, 12 months for group B ] [ Designated as safety issue: Yes ]
    Complications of pregnancy including gestational hypertension, diabetes, preterm labor, disorders of placentation will be collected in all patients with ongoing clinical pregnancies.

  • Congenital Anomalies rate [ Time Frame: 10 months for group A, 12 months for group B ] [ Designated as safety issue: Yes ]
    We will collect all recognized fetal and infant anomalies that occur within the trial.

  • neonatal complication rate [ Time Frame: within one month after labor ] [ Designated as safety issue: Yes ]
    We will collect complications that occur in the neonate including admission to the neonatal intensive care unit (NICU), hospitalization, etc.


Estimated Enrollment: 1180
Study Start Date: June 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fresh embryo transfer group
rFSH/GnRH antagonist will be administered for ovarian stimulation. Two fresh embryos will be transferred at Day 3. Luteal phase support will last 2 weeks for all subjects in this group. Two weeks after embryo transfer, serum human chorionic gonadotropin (HCG) will be measured to determine pregnant or not. If biochemical pregnancy is achieved, luteal phase support will be continued to 10 weeks gestation. Pregnancy complications and final outcome will be followed up till 6 weeks after delivery.
Other: fresh embryo transfer
rFSH/GnRH antagonist will be administered for ovarian stimulation. Oocyte pick-up will be performed when at least two follicles ≥18mm. Two fresh embryos will be transferred at Day 3. Luteal phase support will last 2 weeks for all subjects in this group. Two weeks after embryo transfer, serum HCG will be measured to determine pregnant or not. If biochemical pregnancy is achieved, luteal phase support will be continued to 10 weeks gestation. Pregnancy complications and final outcome will be followed up till 6 weeks after delivery.
Experimental: frozen-thawed embryo transfer group
rFSH/GnRH antagonist will be administered for ovarian stimulation. All embryos will be vitrified in fresh cycle, and at least 2 embryos should be frozen at Day 3. Two months later, two thawed Day 3 embryos will be transferred with hormone replacement therapy (HRT) prepared endometrium. Luteal phase support will last 2 weeks for all subjects in this group. Two weeks after embryo transfer, serum human chorionic gonadotropin (HCG) will be measured to determine pregnant or not. If biochemical pregnancy is achieved, luteal phase support will be continued to 10 weeks gestation. Pregnancy complications and final outcome will be followed up till 6 weeks after delivery.
Other: frozen-thawed embryo transfer
rFSH/GnRH antagonist will be administered for ovarian stimulation. Oocyte pick-up will be performed when at least two follicles ≥18mm. All embryos will be vitrified in fresh cycle, and at least 2 embryos should be frozen at Day 3. Two months later, two thawed Day 3 embryos will be transferred with HRT (hormone replacement therapy) prepared endometrium. Luteal phase support will last 2 weeks for all subjects in this group. Two weeks after embryo transfer, serum HCG will be measured to determine pregnant or not. If biochemical pregnancy is achieved, luteal phase support will be continued to 10 weeks gestation. Pregnancy complications and final outcome will be followed up till 6 weeks after delivery.

Detailed Description:

This will be a multi-center, prospective, randomized (1:1 ratio)clinical trial of frozen-thawed embryo transfer vs. fresh embryo transfer after a uniform gonadotropin-releasing hormone (GnRH) antagonist protocol in infertile PCOS patients receiving IVF therapy. Qualified 1180 patients are randomized into either of two groups: group A will undergo fresh embryo transfer (590 cases), Group B will undergo elective cryopreservation of all embryos followed by transfer of thawed embryos to a programmed endometrium (590 cases). All of the participants will receive recombinant follicule stimulating hormone (rFSH)/GnRH antagonist protocol for ovarian stimulation and standardized luteal phase support.

The target population will be infertile PCOS patients aged between 20 and 35 years, diagnosed by the Chinese PCOS Criteria(i.e. menstrual disorders PLUS either one of the remaining two criteria, hyperandrogenism or polycystic ovaries on ultrasound, with exclusion of secondary causes of hyperandrogenism and ovulation dysfunction). And subjects will be those who are undergoing their first IVF or intracytoplasmatic sperm injection (ICSI) cycle without other known factors interfere reproductive or metabolic functions.

The randomization will take place at the oocyte pick-up day by an on-line randomization system.

The pregnancy test results, pregnancy complications, congenital anomalies neonatal complications will be followed up by checking medical records and telephone calls.

  Eligibility

Ages Eligible for Study:   20 Years to 34 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women diagnosed as PCOS according to Chinese PCOS diagnosis criteria;
  • Women who have ≥1 years history of infertility;
  • Women aged ≥20 and <35 years old;
  • Women with body weight ≥40kg;
  • Women who have at least one of the following indications for IVF or ICSI:

    1. Ovulation dysfunction and failed to become pregnant from ovulation induction treatment;
    2. Tubal factors: unilateral or bilateral tubal obstruction, adhesion, unilateral or bilateral Salpingectomy or tubal ligation;
    3. Male factors: oligoasthenozoospermia, obstructive azoospermia;
  • Women who are undergoing their first cycle of IVF or ICSI;
  • Women who retrieved oocytes number > 3;
  • Women who are capable of giving informed consent.

Exclusion Criteria:

  • Women who underwent unilateral ovariectomy;
  • Women diagnosed as uterus abnormality: malformed uterus (uterus unicorns, septate uterus, duplex uterus, uterus bicomis), adenomyosis, submucous myoma, intrauterine adhesion;
  • Women or their partner with abnormal chromosome karyotype including chromosome polymorphism;
  • Women who have experienced recurrent spontaneous abortion (including biochemical pregnancy abortion) more than 2 times;
  • Women with medical condition that represent contraindication to assisted reproductive technology and/or pregnancy;
  • Women who has developed severe OHSS before oocyte pick-up day;
  • Women with retrieved oocytes number ≤3;
  • Women who are unable to comply with the study procedures.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01841528

Locations
China, Anhui
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
China, Gansu
The First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, China, 730000
China, Guangdong
The sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510655
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510120
China, Guangxi
Guangxi Maternal and Child Health Hospital
Nanning, Guangxi, China, 530003
China, Hubei
Renmin Hospital of Wuhan University
Wuhan, Hubei, China, 430060
China, Jiangsu
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
China, Jiangxi
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China, 330006
China, Liaoning
Reproductive Medicine Center in Shenyang City
Shenyang, Liaoning, China, 110000
China, Shandong
Reproductive medical hospital affiliated to Shandong University
Jinan, Shandong, China, 250001
Yuhuangding Hospital in Yantai
Yantai, Shandong, China, 264000
China, Shanghai
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai, China, 200127
China, Shanxi
Shanxi Provincial Maternity and Children's Hospital
Xi'an, Shanxi, China, 710003
China, Zhejiang
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China, 310016
Sponsors and Collaborators
Zi-jiang Chen
Jiangsu Province Hospital
Sixth Affiliated Hospital, Sun Yat-sen University
Anhui Medical University
RenJi Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
LanZhou University
Guangxi provincial maternal and chidren's hospital
Renmin Hospital of Wuhan University
Yuhuangding Hospital of Yantai
Jiangxi Maternal and Child Health Hospital
Sir Run Run Shaw Hospital
Shanxi Provincial Maternity and Children's Hospital
Reproductive Medicine Center in Shenyang City
Investigators
Principal Investigator: Zi-jiang Chen, MD Repreductive medical hospital affiliated to Shandong University
  More Information

No publications provided by Shandong University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zi-jiang Chen, Director of Reproductive medical center of Shandong University, Shandong University
ClinicalTrials.gov Identifier: NCT01841528     History of Changes
Other Study ID Numbers: SDUIVF001
Study First Received: April 18, 2013
Last Updated: April 14, 2014
Health Authority: China: Ministry of Health

Keywords provided by Shandong University:
Polycystic Ovary Syndrome
Infertility
In-vitro fertilization
fresh embryo transfer
frozen-thawed embryo transfer

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Infertility
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014