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

The Effect of Incremental Clomiphene Citrate(CC) Doses in Successive Induction Cycles on the Endogenous Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Steroid Hormone Responses to Treatment

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04210765

Enrollment

Registered

2019-12-26

Start date

2019-08-02

Completion date

2020-05-25

Last updated

2021-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovulation Disorder, Unexplained Infertility

Keywords

infertility, unexplained infertility, ovulation induction, clomiphene citrate

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.

Interventions

DRUGClomiphene Citrate

Clomiphene citrate used in incremental doses in nonresponsive cases.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 35 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026