Luteal Phase Versus Follicular Phase Administration of Clomiphene Citrate in PCOS, A Randomized Controlled Trial

NCT02024984 | Unknown Phase 1 DMC

• 1 other identifier: LPFPCCPCOS
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

INTRODUCTION Polycystic ovary syndrome (PCOS) is one of the most common female endocrine disorders (Fauser et al., 2011). It is a complex, heterogeneous disorder of uncertain aetiology, but there is strong evidence that it can, to a large degree, be classified as a genetic disease (Fauser et al., 2011). Genetic and environmental contributors to hormonal disturbances combine with other factors, including obesity (Diamanti-Kandarakis et al., 2006). Ovarian dysfunction and hypothalamic pituitary abnormalities contribute to the etiology of PCOS (Doi et al., 2005). It produces symptoms in approximately 5% to 10% of women of reproductive age (12-45 years old). It is thought to be one of the leading causes of female subfertility (Goldenberg and Glueck, 2008). Its prevalence has increased with the use of different diagnostic criteria and has recently been shown to be 18% (17.8 ± 2.8%) in the first community-based prevalence study based on current Rotterdam diagnostic criteria (March et al., 2010). AIM OF THE WORK The study will compare the luteal phase (early) administration of clomiphene citrate to the conventional (late) administration of the same drug in the follicular phase as regards ovarian response in PCOS. Research Question What is the difference between administration of clomiphene citrate in the luteal phase and the follicular phase for ovulation induction in women with PCOS? Research Hypothesis Luteal phase administration of clomiphene citrate protocol gives better results than conventional administration of clomiphene citrate in the follicular phase as regards ovarian response in PCOS.

Conditions

PCOS

Keywords

LPFPCCPCOS

Outcome Measures

Primary Outcomes (1)

• the total number of follicles, number of follicles > 14 mm in diameter, number of follicles > 18 mm in diameter.

  the total number of follicles, number of follicles \> 14 mm in diameter, number of follicles \> 18 mm in diameter.

  6 months

Secondary Outcomes (1)

• endometrial thickness

  6 months

Study Arms (2)

Group A

EXPERIMENTAL

Luteal Phase Administration of Clomiphene (50mg twice per day for 5 days)

Drug: Clomiphene Citrate

Group B

ACTIVE COMPARATOR

Follicular Phase Administration of Clomiphene Citrate in PCOS(50mg twice per day for 5 days)

Drug: Clomiphene Citrate

Interventions

Clomiphene Citrate DRUG

Group A (study group) 'Luteal Clomid': will include 45 patients to whom 100 mg of CC will be administrated daily for five days starting the next day after finishing MPA (medroxyprogesterone acetate) 10 mg tablet for five days, for one menstrual cycle, then a wash out period for another menstrual cycle, then the group treatment plan is shifted to administration of 100 mg of CC daily for five days starting on day 2 of the cycle induced by MPA for another menstrual cycle. Group B (control group)'Follicular Clomid': will include 45 patients to whom 100 mg of CC will be administrated daily for five days starting on day 2 of the cycle induced by MPA, for one menstrual cycle, then a wash out period for another menstrual cycle, then the group treatment plan is shifted to administration of 100 mg of CC daily for five days starting the next day after finishing MPA (medroxyprogesterone acetate) 10 mg tablet for five days for another menstrual cycle.

Also known as: Clomid

Group A; Group B

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A. Women aged 20-40 years old.
• Oligo / anovulation
• Hyperandrogenism and/or Hyperandrogenemia
• Polycystic ovaries by U/S i.e. at least one ovary showing either 1 - 12 more follicles (2-9 mm in diameter) or ovarian volume \> 10 mm.

You may not qualify if:

• A. Age \< 20 or \> 40. B. Major pelvic pathology. C. Ovarian masses. D. Infertility due to causes other than ovarian factors e.g.
• Bilateral tubal block
• Congenital anomaly of the uterus
• Male factor of infertility E. Liver disease F. Other endocrinopathies e.g. hyperprolactinemia, Lipoid Congenital Adrenal Hyperplasia (LCAH), hypothyroidism, hyperthyroidism and Cushing's disease.

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (2)

Ain Shams Maternity Hospital

Cairo, Cairo Governorate, Egypt

RECRUITING

Ain Shams Maternity Hospital

Cairo, Cairo Governorate, Egypt

RECRUITING

MeSH Terms

Interventions

Clomiphene

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Mohammed AA ALI, MBBCH

  Resident Doctor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Elsayed elbohoty, MD

CONTACT

+201005646995; elbohoty79@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in OB GYN

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 31, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 11, 2014

Record last verified: 2014-03

Locations

EG (2)