Incremental Clomiphene Citrate Doses in Successive Cycles and FSH, LH and Steroid Hormone Levels
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Clomiphene citrate group 1 Clomiphene citrate dose 50mg/day for 5 days starting on cycle day (2-4). |
Drug: Clomiphene Citrate
Clomiphene citrate used in incremental doses in nonresponsive cases.
Other Names:
|
| Active Comparator: 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). |
Drug: Clomiphene Citrate
Clomiphene citrate used in incremental doses in nonresponsive cases.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- conception rate [15-20 days following intrauterine insemination.]
beta-hCG (IU/L)measured with ELISA.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bagcilar Teaching and Research Hospital | Istanbul | Bagcilar | Turkey | 34200 |
Sponsors and Collaborators
- Bagcilar Training and Research Hospital
Investigators
- Principal Investigator: Evrim E Kovalak, MD, Bagcilar Training and Research Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 2019.08.1.04.061