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Trial record 42 of 2076 for:    ESTRADIOL

Concomitant CC and E2 Versus CC Alone in Ovulation Induction

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ClinicalTrials.gov Identifier: NCT02186782
Recruitment Status : Unknown
Verified March 2017 by Maher elesawi kamel elesawi, Mansoura University.
Recruitment status was:  Recruiting
First Posted : July 10, 2014
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Maher elesawi kamel elesawi, Mansoura University

Brief Summary:
The purpose of this study is to evaluate the effect of concomitant administration of estradiol during use of clomiphene citrate (CC) for induction of ovulation in infertile women.

Condition or disease Intervention/treatment Phase
Infertility Anovulation Drug: Clomiphene citrate and Estradiol Drug: Clomiphene citrate and Placebo Phase 4

Detailed Description:
Women will be randomly divided into two groups; CC-E2 group and CC group. Women in the CC-E2 group will receive CC (100 mg/day for 5 consecutive days from day 2 of cycle) and estradiol (2 mg/day for 5 consecutive days from day 2 of cycle). Women in the CC group will receive CC (100 mg/day for 5 consecutive days from day 2 of cycle) and placebo mimic estradiol (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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Concomitant Clomiphene Citrate and Estradiol Versus Clomiphene Citrate Alone in Ovulation Induction: a Randomized Controlled Trial
Study Start Date : June 2014
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : August 2018


Arm Intervention/treatment
Active Comparator: Clomiphene citrate-Estradiol group
Women will receive clomiphene citrate and estradiol
Drug: Clomiphene citrate and Estradiol
Women will receive clomiphene citrate (100 mg/day for 5 consecutive days from day 2 of cycle) and estradiol (2 mg/day for 5 consecutive days from day 2 of cycle)
Other Name: Clomid and Estradiol valerate

Active Comparator: Clomiphene citrate group
Women will receive clomiphene citrate and placebo
Drug: Clomiphene citrate and Placebo
Women will receive clomiphene citrate (100 mg/day for 5 consecutive days from day 2 of cycle) and placebo (for 5 consecutive days from day 2 of cycle)
Other Name: Clomid and Placebo




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Endometrial thickness on day of HCG administration [ Time Frame: 3 months ]
    Endometrial thickness by TVS on day of HCG administration


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

  2. 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



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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infertile women with eugonadotrophic anovulation/oligoovulation.
  • Unexplained infertility.

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 anovulation/oligoovulation.
  • Previous history of ovarian surgery or surgical removal of one ovary.
  • Previous exposure to cytotoxic drugs or pelvic irradiation.
  • 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): NCT02186782


Contacts
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Contact: Maher E Kamel Elesawi, Dr +201016103662 maherelesawi@yahoo.com
Contact: Ahmed M Badawy, Prof +201282848485 ambadawy@yahoo.com

Locations
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Egypt
Obstetrics and Gynecology Department in Mansoura University Hospital Recruiting
Mansoura, Dakahlia, Egypt, 35111
Private practice settings Recruiting
Mansoura, Dakahlia, Egypt
Contact: Ahmed M Badawy, Prof    +201282848485    ambadawy@yahoo.com   
Principal Investigator: Ahmed M Badaway, Prof         
Private practice settings Recruiting
Mit Ghamr, Dakahlia, Egypt
Contact: Maher E Kamel Elesawi, Dr    +20104523494    maherelesawi@yahoo.com   
Principal Investigator: Maher E Kamel Elesawi, Dr         
Sponsors and Collaborators
Maher elesawi kamel elesawi
Investigators
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Principal Investigator: Ahmed M Badawy, Prof Mansoura University
Study Director: Maher E Kamel Elesawi, Dr Mansoura University
Study Director: Mohamed S Abdelhafez, Dr Mansoura University

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Responsible Party: Maher elesawi kamel elesawi, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT02186782     History of Changes
Other Study ID Numbers: ME1
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Maher elesawi kamel elesawi, Mansoura University:
Clomiphene citrate
Estradiol
Endometrial thickness
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Infertility
Anovulation
Genital Diseases, Male
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Sodium Citrate
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Estrogen Antagonists