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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 : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Sayed Abdelhafez, 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 Phase 4

Detailed Description:
Women will be randomly divided into two groups; CC-Prednisolone group and CC group. Women in the CC-Prednisolone group will receive CC (150 mg/day for 5 consecutive days from day 2 of cycle) and prednisolone (5 mg/day for 10 consecutive days from day 2 of cycle). Women in the CC group will receive CC alone (150 mg/day for 5 consecutive days from day 2 of 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 midluteal 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : September 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 cycle) and prednisolone (5 mg/day for 10 consecutive days from day 2 of cycle)
Other Name: Clomid and Hostacortin-H

Active Comparator: Clomiphene citrate group
Women will receive clomiphene citrate alone
Drug: Clomiphene citrate
Women will receive clomiphene citrate alone (150 mg/day for 5 consecutive days from day 2 of cycle)
Other Name: Clomid




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

Locations
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
Obstetrics and Gynecology Department in Port Said University Recruiting
Port Said, Egypt
Contact: Waleed El-refaie, Dr         
Sponsors and Collaborators
Mohamed Sayed Abdelhafez
Investigators
Principal Investigator: Mahmoud M Abdelrazik, Dr Mansoura University
Study Director: Mohamed S Abdelhafez, Dr Mansoura University
Study Director: Mahmoud Thabet, D Mansoura University
Study Director: Waleed El-refaie, Dr Mansoura University
Study Chair: Ahmed Badawy, Prof Mansoura University

Responsible Party: Mohamed Sayed Abdelhafez, 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: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mohamed Sayed Abdelhafez, Mansoura University:
PCOS
Clomiphene citrate resistant
Prednisolone

Additional relevant MeSH terms:
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
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action