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

Ain Shams University

Status: Unknown

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Clomiphene Citrate; Diagnostic Test: Follicular growth

Study type: Interventional

Funder types: Other

Identifiers

NCT03316469

Narges Essam protocol 2017

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Group A: CC & ovulation

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Follicular growth

Drug: Clomiphene Citrate

Group B: CC & no ovulation

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Follicular growth

Drug: Clomiphene Citrate