Incremental Clomiphene Citrate Doses in Successive Cycles and FSH, LH and Steroid Hormone Levels

Phase 4

Completed

• Conditions: Unexplained Infertility; Ovulation Disorder
• Interventions: Drug: Clomiphene Citrate

• Registration Number: NCT04210765
• Lead Sponsor: Bagcilar Training and Research Hospital

Brief Summary

This study was planned to assess the initial and endogenous FSH, LH and steroid responses to incremental CC doses in successive ovulation induction cycles to treat anovulation in patients with unexplained infertility.

Detailed Description

In the Bagcilar Research and Training Hospital Obstetrics and Gynecology department outpatient clinic for infertility, the basal gonadotropin and androgen levels are routinely measured. In unexplained infertility couples with normal ovarian reserves the first line drug used for ovulation induction is CC. The starting dose is 50mg/day and the treatment is started within the 2nd to the 5th days of the menstrual cycle and continued for 5 days. Starting on the 2nd-3rd day following the last dose of the drug, the follicular growth was monitored with the transvaginal ultrasound and blood levels of hormones including FSH, LH, estradiol, progesterone, androstenedione, testosterone, and dehydroepiandrosterone sulphate were measured every 2-3 days. In this follow-up, if no follicular growth was observed day21 of the cycle, the CC dose was increased to CC 100mg/day (2X1, 50mg). If follicular growth and ovulation is achieved with no concluding conception, the same dose of CC is used in the following 2-3 cycles. When a maximum number of 2 dominant follicles are obtained ovulation is triggered with recombinant human chorionic gonadotropin (rhCG) and timed coit or intrauterine insemination is conducted.

Study Timeline

• Study Start: 2019-08-02
• Status Verified: 2019-12
• Study First Submitted: 2019-12-13
• Study First Submitted QC: 2019-12-24
• Study First Posted: 2019-12-26
• Primary Completion: 2020-05-20
• Study Completion: 2020-05-25
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• 20-35 years of age
• unexplained infertility
• first-line treatment
• Normal or increased ovarian reserve
• lack of ovulatory response to CC 50mg for 5 days

Exclusion Criteria

• Male factor
• Tubal Factor
• Severe endometriosis
• Previous ovarian surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clomiphene citrate group 1	Clomiphene Citrate	Clomiphene citrate dose 50mg/day for 5 days starting on cycle day (2-4).
Clomiphene citrate group 2	Clomiphene Citrate	Non-responsive to ovulation induction with Clomiphene Citrate with dose:50mg/day; and treated with dose:100mg/day in the succeeding cycle for 5 days, starting on cycle day (2-4).

Primary Outcome Measures

Name	Time	Method
Changes in the endogenous blood levels of FSH, LH in successive cycles	Menstrual cycle at day 3 and day 9 and the trigger day respectively (each cycle is 28 days	FSH (mIU/ml), LH (mIU/ml) blood levels measured with Enzyme-Linked ImmunoSorbent Assay (ELISA) tests.
Changes in the endogenous blood levels of steroids (including Androstenedione, Progesterone, Testosterone, estradiol) in successive cycles	Menstrual cycle at day 3 and day 9 and the trigger day respectively (each cycle is 28 days)	Blood levels of steroids: Androstenedione (ng/ml), Progesterone (ng/ml), Testosterone (ng/ml), estradiol (pg/ml) measured with ELISA tests.

Secondary Outcome Measures

Name	Time	Method
conception rate	15-20 days following intrauterine insemination.	beta-hCG (IU/L)measured with ELISA.

Trial Locations

Locations (1)

Bagcilar Teaching and Research Hospital; 🇹🇷 Istanbul, Bagcilar, Turkey