Clinical trial NCT04210765: Incremental Clomiphene Citrate Doses in Successive Cycles and FSH, LH and Steroid Hormone Levels
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Unexplained Infertility
Ovulation Disorder
Keywords: infertility
unexplained infertility
ovulation induction
clomiphene citrate
Lead sponsor: Bagcilar Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2019-12-26
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in the endogenous blood levels of FSH, LH in successive cycles
timeFrame: Menstrual cycle at day 3 and day 9 and the trigger day respectively (each cycle is 28 days
measure: Changes in the endogenous blood levels of steroids (including Androstenedione, Progesterone, Testosterone, estradiol) in successive cycles
timeFrame: Menstrual cycle at day 3 and day 9 and the trigger day respectively (each cycle is 28 days)
Secondary outcomes:
measure: conception rate
timeFrame: 15-20 days following intrauterine insemination.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bagcilar Teaching and Research Hospital
state: Bagcilar
Study officials:
affiliation: Bagcilar Training and Research Hospital
name: Evrim E Kovalak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ozyurek ES, Yoldemir T, Artar G. Androstenedione response to recombinant human FSH is the most valid predictor of the number of selected follicles in polycystic ovarian syndrome: (a case-control study). J Ovarian Res. 2017 May 12;10(1):34. doi: 10.1186/s13048-017-0330-7.
citation: Hager M, Horath S, Frigo P, Koch M, Marculescu R, Ott J. Changes in serum markers of patients with PCOS during consecutive clomiphene stimulation cycles: a retrospective study. J Ovarian Res. 2019 Oct 4;12(1):91. doi: 10.1186/s13048-019-0564-7.