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

Unexplained Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04210765
• Other study ID #: 2019.08.1.04.061
• Status: Completed
• Phase: Phase 4
• Start date: August 2, 2019
• Est. completion date: May 25, 2020

Study information

• Verified date: December 2019
• Source: Bagcilar Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 25, 2020
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Ovulation Disorder
• Unexplained Infertility

Intervention

Drug:
• Clomiphene Citrate
Clomiphene citrate used in incremental doses in nonresponsive cases.

Locations

Country	Name	City	State
Turkey	Bagcilar Teaching and Research Hospital	Istanbul	Bagcilar

Sponsors (1)

Lead Sponsor	Collaborator
Bagcilar Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Hager M, Hörath 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the endogenous blood levels of FSH, LH in successive cycles	FSH (mIU/ml), LH (mIU/ml) blood levels measured with Enzyme-Linked ImmunoSorbent Assay (ELISA) tests.	Menstrual cycle at day 3 and day 9 and the trigger day respectively (each cycle is 28 days
Primary	Changes in the endogenous blood levels of steroids (including Androstenedione, Progesterone, Testosterone, estradiol) in successive cycles	Blood levels of steroids: Androstenedione (ng/ml), Progesterone (ng/ml), Testosterone (ng/ml), estradiol (pg/ml) measured with ELISA tests.	Menstrual cycle at day 3 and day 9 and the trigger day respectively (each cycle is 28 days)
Secondary	conception rate	beta-hCG (IU/L)measured with ELISA.	15-20 days following intrauterine insemination.