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Adding Prednisolone During Ovulation Induction With CC in Lean Women With CC Resistant PCOS

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ClinicalTrials.gov Identifier: NCT02344888
Recruitment Status : Recruiting
First Posted : January 26, 2015
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Mahmoud Thabet, Mansoura University

Brief Summary:
The purpose of this study is to evaluate the effect of concomitant administration of prednisolone during use of clomiphene citrate (CC) for induction of ovulation in infertile lean women having CC resistant polycystic ovarian syndrome (PCOS).

Condition or disease Intervention/treatment Phase
Infertility Polycystic Ovarian Syndrome Drug: Clomiphene citrate and Prednisolone Drug: Clomiphene citrate and folic acid Phase 4

Detailed Description:
Women will be randomly divided into two groups; CC-Prednisolone group and CC-placebo group. Women in the CC-Prednisolone group will receive CC (150 mg/day for 5 consecutive days from day 2 of the cycle) and prednisolone tablet (5 mg/day for 10 consecutive days from day 2 of the cycle). Women in the CC-placebo group will receive CC alone (150 mg/day for 5 consecutive days from day 2 of the cycle) and folic acid tablet (0.5 mg/day for 10 consecutive days from day 2 of the cycle). Transvaginal sonography (TVS) scan will be performed regularly for monitoring of follicular growth (folliculometry); starting from day 10 of the stimulation cycle and repeated every 2-3 days. When there will be at least one follicle ≥ 18 mm in diameter, final oocyte maturation will be induced by intramuscular administration of 10000 IU of human chorionic gonadotropin (HCG) and timed intercourse will be advised. If there will be no follicle ≥ 12 mm by day 16 of the cycle, monitoring of follicular growth will be discontinued and the cycle will be presumed to be anovulatory. Ovulation will be documented by TVS scan one week after triggering of oocyte maturation and will be confirmed by assessing the mid-luteal serum progesterone level. Each woman will be subjected to ovarian stimulation for a maximum of 3 consecutive cycles except if she gets pregnant in the first or second cycle

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adding Prednisolone During Ovulation Induction With Clomiphene Citrate in Lean Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome
Study Start Date : February 2015
Actual Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019


Arm Intervention/treatment
Active Comparator: Clomiphene citrate-Prednisolone group
Women will receive clomiphene citrate and prednisolone
Drug: Clomiphene citrate and Prednisolone
Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of the cycle) and prednisolone (5 mg/day for 10 consecutive days from day 2 of the cycle)
Other Name: Clomid and Hostacortin-H

Active Comparator: Clomiphene citrate-placebo group
Women will receive clomiphene citrate and folic acid 0.5mg (placebo)
Drug: Clomiphene citrate and folic acid
Women will receive clomiphene citrate alone (150 mg/day for 5 consecutive days from day 2 of the cycle) and folic acid (0.5 mg/day for 10 consecutive days from day 2 of the cycle)
Other Name: Clomid and folic acid




Primary Outcome Measures :
  1. Ovulation rate [ Time Frame: 3 months ]
    Number of ovulatory cycles divided by the number of stimulation cycles


Secondary Outcome Measures :
  1. Number of ovarian follicles ≥ 18 mm on day of HCG administration [ Time Frame: 3 months ]
    Number of ovarian follicles ≥ 18 mm by TVS on day of HCG administration

  2. Endometrial thickness on day of HCG administration [ Time Frame: 3 months ]
    Endometrial thickness by TVS on day of HCG administration

  3. Clinical pregnancy rate [ Time Frame: 6-8 weeks gestational age ]
    Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 6-8 weeks gestational age) divided by the number of women



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infertile lean women with PCOS as defined by the Rotterdam criteria.
  • CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles).

Exclusion Criteria:

  • Age < 20 or > 35 years.
  • Body mass index (BMI) < 18.5 kg/m2 or > 25 kg/m2.
  • Presence of any infertility factor other than anovulatory PCOS.
  • Previous history of ovarian surgery or surgical removal of one ovary.
  • Previous exposure to cytotoxic drugs or pelvic irradiation.
  • Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months.
  • Metabolic or hormonal abnormalities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02344888


Contacts
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Contact: Mahmoud M Abdelrazik, Dr +201005548881 dr_mahmoudhosam@yahoo.com

Locations
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Egypt
Obstetrics and Gynecology Department in Mansoura University Hospital Recruiting
Mansourah, Dakahlia, Egypt, 35111
Contact: Mahmoud M Abdelrazik, Dr    +201005548881    dr_mahmoudhosam@yahoo.com   
Private practice settings Recruiting
Mansourah, Dakahlia, Egypt
Sponsors and Collaborators
Mahmoud Thabet
Investigators
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Principal Investigator: Mahmoud M Abdelrazik, Dr Mansoura University
Study Director: Mahmoud Thabet, D Mansoura University

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Responsible Party: Mahmoud Thabet, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT02344888     History of Changes
Other Study ID Numbers: MMA1
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mahmoud Thabet, Mansoura University:
PCOS
Clomiphene citrate resistant
Prednisolone

Additional relevant MeSH terms:
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Syndrome
Infertility
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Sodium Citrate
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Folic Acid
Vitamin B Complex
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants
Calcium Chelating Agents