Anti-Mullerian Hormone as Predictor of Ovarian Responce to Clomiphene Citrate in PCOS

Not Applicable

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Clomiphene Citrate; Diagnostic Test: Follicular growth

• Registration Number: NCT03316469
• Lead Sponsor: Ain Shams University

Brief Summary

Polycystic ovary syndrome (PCOS) is found in 5% to 6% of women of reproductive age. It affects women's reproductive capability; thus patients have risks of infertility, miscarriage, and complicated pregnancy. A study revealed that the prevalence of oligoovulation or anovulation in patients with PCOS ranged from 65% to 80%. Anti-Mullerian Hormone (AMH) is an important regulator in the ovary that play a rule during development and function. It is suspected to affect clomiphene citrate (cc) resistance. In this study the investigator will assess the accuracy of AMH prediction of response to cc in women with PCOS.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-10
• Study First Submitted QC: 2017-10-17
• Study First Posted: 2017-10-20
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-26
• Last Update Posted: 2018-06-27
• Study Start: 2018-07
• Primary Completion: 2018-10
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Women diagnosed with PCOS
• Women 20-35 years old.
• BMI ≤30 kg/m without previous ovulation induction.
• Partners with normal semen parameters Parameter World Health Organization (WHO) 2010 Volume1.5 ml Concentration 15 million/ml Progressive motility 32% Normal forms 4%

Exclusion Criteria

• Women with evidence of hyper-or hypothyroidism, hyperprolactinemia, Cushing's syndrome, congenital adrenal hyperplasia or androgen-secreting tumors.
• Women with factors of infertility other than PCOS
• Women with incomplete data.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B: CC & no ovulation	Follicular growth	AMH level is measured before Clomiphene citrate 100 mg daily for 5 days \& detecting Follicular growth assessment by TVU will be performed at day 12 of the menstrual period. Successful and unsuccessful follicular growth will be compared according to the subjects' respective AMH levels.
Group A: CC & ovulation	Follicular growth	AMH level is measured before Clomiphene citrate 100 mg daily for 5 days \& detecting Follicular growth assessment by TVU will be performed at day 12 of the menstrual period. Successful and unsuccessful follicular growth will be compared according to the subjects' respective AMH levels.
Group B: CC & no ovulation	Clomiphene Citrate	AMH level is measured before Clomiphene citrate 100 mg daily for 5 days \& detecting Follicular growth assessment by TVU will be performed at day 12 of the menstrual period. Successful and unsuccessful follicular growth will be compared according to the subjects' respective AMH levels.
Group A: CC & ovulation	Clomiphene Citrate	AMH level is measured before Clomiphene citrate 100 mg daily for 5 days \& detecting Follicular growth assessment by TVU will be performed at day 12 of the menstrual period. Successful and unsuccessful follicular growth will be compared according to the subjects' respective AMH levels.

Primary Outcome Measures

Name	Time	Method
AMH in prediction of Ovulation in women with PCOS.	10 days	AMH level is measured 10 days before expected date of ovulation then correlated to ovulation either successfully or not.