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
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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 |
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PCOS | Drug: Clomiphene Citrate | Phase 1 |

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 |

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

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
Contact: Ahmed Elsayed elbohoty, MD | +201005646995 | elbohoty79@yahoo.com |
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 |
Principal Investigator: | Mohammed AA ALI, MBBCH | Resident Doctor |
Responsible Party: | Ahmed E Elbohoty, MD, Lecturer in OB GYN, Ain Shams Maternity Hospital |
ClinicalTrials.gov Identifier: | NCT02024984 |
Other Study ID Numbers: |
LPFPCCPCOS |
First Posted: | December 31, 2013 Key Record Dates |
Last Update Posted: | March 11, 2014 |
Last Verified: | March 2014 |
LPFPCCPCOS |
Clomiphene Enclomiphene Zuclomiphene 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 |