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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-02

Study Completion Date

2020-05-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Unexplained Infertility Ovulation Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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Clomiphene citrate group 1

Clomiphene citrate dose 50mg/day for 5 days starting on cycle day (2-4).

Group Type ACTIVE_COMPARATOR

Clomiphene Citrate

Intervention Type DRUG

Clomiphene citrate used in incremental doses in nonresponsive cases.

Clomiphene citrate group 2

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).

Group Type ACTIVE_COMPARATOR

Clomiphene Citrate

Intervention Type DRUG

Clomiphene citrate used in incremental doses in nonresponsive cases.

Interventions

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Clomiphene Citrate

Clomiphene citrate used in incremental doses in nonresponsive cases.

Intervention Type DRUG

Other Intervention Names

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CC

Eligibility Criteria

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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