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

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ClinicalTrials.gov Identifier: NCT02024984
Recruitment Status : Unknown
Verified March 2014 by Ahmed E Elbohoty, MD, Ain Shams Maternity Hospital.
Recruitment status was:  Recruiting
First Posted : December 31, 2013
Last Update Posted : March 11, 2014
Sponsor:
Information provided by (Responsible Party):
Ahmed E Elbohoty, MD, Ain Shams Maternity Hospital

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.


Condition or disease Intervention/treatment Phase
PCOS Drug: Clomiphene Citrate Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Luteal Phase Versus Follicular Phase Administration of Clomiphene Citrate in PCOS, A Randomized Controlled Trial
Study Start Date : November 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
Luteal Phase Administration of Clomiphene (50mg twice per day for 5 days)
Drug: Clomiphene Citrate

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.

Other Name: Clomid

Active Comparator: Group B
Follicular Phase Administration of Clomiphene Citrate in PCOS(50mg twice per day for 5 days)
Drug: Clomiphene Citrate

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.

Other Name: Clomid




Primary Outcome Measures :
  1. the total number of follicles, number of follicles > 14 mm in diameter, number of follicles > 18 mm in diameter. [ Time Frame: 6 months ]
    the total number of follicles, number of follicles > 14 mm in diameter, number of follicles > 18 mm in diameter.


Secondary Outcome Measures :
  1. endometrial thickness [ Time Frame: 6 months ]
    endometrial thickness



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A. Women aged 20-40 years old.

B. Patients with diagnosis of PCOS based on the 2003 ESHRE/ASRM (Rotterdam) criteria: to include two of the following, in addition to exclusion of related disorders:

  1. Oligo / anovulation
  2. Hyperandrogenism and/or Hyperandrogenemia
  3. 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.

Exclusion Criteria:

A. Age < 20 or > 40. B. Major pelvic pathology. C. Ovarian masses. D. Infertility due to causes other than ovarian factors e.g.

  1. Bilateral tubal block
  2. Congenital anomaly of the uterus
  3. Male factor of infertility E. Liver disease F. Other endocrinopathies e.g. hyperprolactinemia, Lipoid Congenital Adrenal Hyperplasia (LCAH), hypothyroidism, hyperthyroidism and Cushing's disease.

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): NCT02024984


Contacts
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Contact: Ahmed Elsayed elbohoty, MD +201005646995 elbohoty79@yahoo.com

Locations
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Egypt
Ain Shams Maternity Hospital Recruiting
Cairo, Egypt
Contact: Ahmed EH Elbohoty, MD    00201005646995    elbohoty79@yahoo.com   
Sub-Investigator: Mohammed Abdemoez, MBBCh         
Principal Investigator: Ahmed EH Elbohoty, MD         
Ain Shams Maternity Hospital Recruiting
Cairo, Egypt
Contact: Ahmed Elsayed Elbohoty, MD         
Principal Investigator: Ahmed EH Elbohoty, MD         
Sponsors and Collaborators
Ain Shams Maternity Hospital
Investigators
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Principal Investigator: Mohammed AA ALI, MBBCH Resident Doctor

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Responsible Party: Ahmed E Elbohoty, MD, Lecturer in OB GYN, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT02024984     History of Changes
Other Study ID Numbers: LPFPCCPCOS
First Posted: December 31, 2013    Key Record Dates
Last Update Posted: March 11, 2014
Last Verified: March 2014
Keywords provided by Ahmed E Elbohoty, MD, Ain Shams Maternity Hospital:
LPFPCCPCOS
Additional relevant MeSH terms:
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Citric Acid
Sodium Citrate
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators