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

Bagcilar Training and Research Hospital

Status and phase: Completed; Phase 4

Conditions: Unexplained Infertility; Ovulation Disorder

Treatments: Drug: Clomiphene Citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT04210765

2019.08.1.04.061

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Clomiphene citrate group 1

Active Comparator group

Description:

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

Treatment:

Drug: Clomiphene Citrate

Clomiphene citrate group 2

Active Comparator group

Description:

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).

Treatment:

Drug: Clomiphene Citrate