Incremental Clomiphene Citrate Doses in Successive Cycles and FSH, LH and Steroid Hormone Levels
Primary Purpose
Unexplained Infertility, Ovulation Disorder
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Clomiphene Citrate
Sponsored by
About this trial
This is an interventional diagnostic trial for Unexplained Infertility focused on measuring infertility, unexplained infertility, ovulation induction, clomiphene citrate
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
Sites / Locations
- Bagcilar Teaching and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Clomiphene citrate group 1
Clomiphene citrate group 2
Arm Description
Clomiphene citrate dose 50mg/day for 5 days starting on cycle day (2-4).
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).
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
conception rate
beta-hCG (IU/L)measured with ELISA.
Full Information
NCT ID
NCT04210765
First Posted
December 13, 2019
Last Updated
February 2, 2021
Sponsor
Bagcilar Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04210765
Brief Title
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
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
August 2, 2019 (Actual)
Primary Completion Date
May 20, 2020 (Actual)
Study Completion Date
May 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bagcilar Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unexplained Infertility, Ovulation Disorder
Keywords
infertility, unexplained infertility, ovulation induction, clomiphene citrate
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clomiphene citrate group 1
Arm Type
Active Comparator
Arm Description
Clomiphene citrate dose 50mg/day for 5 days starting on cycle day (2-4).
Arm Title
Clomiphene citrate group 2
Arm Type
Active Comparator
Arm 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).
Intervention Type
Drug
Intervention Name(s)
Clomiphene Citrate
Other Intervention Name(s)
CC
Intervention Description
Clomiphene citrate used in incremental doses in nonresponsive cases.
Primary Outcome Measure Information:
Title
Changes in the endogenous blood levels of FSH, LH in successive cycles
Description
FSH (mIU/ml), LH (mIU/ml) blood levels measured with Enzyme-Linked ImmunoSorbent Assay (ELISA) tests.
Time Frame
Menstrual cycle at day 3 and day 9 and the trigger day respectively (each cycle is 28 days
Title
Changes in the endogenous blood levels of steroids (including Androstenedione, Progesterone, Testosterone, estradiol) in successive cycles
Description
Blood levels of steroids: Androstenedione (ng/ml), Progesterone (ng/ml), Testosterone (ng/ml), estradiol (pg/ml) measured with ELISA tests.
Time Frame
Menstrual cycle at day 3 and day 9 and the trigger day respectively (each cycle is 28 days)
Secondary Outcome Measure Information:
Title
conception rate
Description
beta-hCG (IU/L)measured with ELISA.
Time Frame
15-20 days following intrauterine insemination.
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women with unexplained infertility
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evrim E Kovalak, MD
Organizational Affiliation
Bagcilar Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bagcilar Teaching and Research Hospital
City
Istanbul
State/Province
Bagcilar
ZIP/Postal Code
34200
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28494798
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.
Results Reference
background
PubMed Identifier
31585548
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.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://dremrahkovalak.com/wp-content/uploads/2019/12/registration.pdf
Available IPD/Information Comments
unfinished
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Incremental Clomiphene Citrate Doses in Successive Cycles and FSH, LH and Steroid Hormone Levels
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