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Comparison of Recombinant Follicle Stimulating Hormone and the Combination of Recombinant Follicle Stimulating Hormone With Clomiphene Citrate in Stimulated Intrauterine Insemination Cycles

Comparison of Recombinant Follicle Stimulating Hormone and the Combination of Recombinant Follicle Stimulating Hormone With Clomiphene Citrate in Stimulated Intrauterine Insemination Cycles: A Prospective Randomized Controlled Multicentric Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05670795
Enrollment
254
Registered
2023-01-04
Start date
2023-01-01
Completion date
2024-05-01
Last updated
2024-02-02

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

Conditions

Infertility Unexplained

Keywords

ovulation induction, iui

Brief summary

The aim of study is to evaluate the results of two different protocols for ovulation induction during IUI cycles. All patients undergo IUI cycles are randomly divided in to two groups. the first group is recombinant follicle stimulating hormone and the second group is the combination of recombinant follicle stimulating hormone with clomiphene citrate.

Detailed description

Approximately %10-15 of couples of reproductive age, have infertility issues. %30-40 male factor, %40-50 female factor, and %20-25 both play a role in infertility etiology. Contributory factors of cases are %30-40 male factors, %40-50 female factors, and %20-25 mixed type. Ovulation induction and intrauterine insemination (IUI) are the main treatments for infertility. IUI is accepted as the most used treatment procedure according to other assisted reproductive techniques because it has lower costs, can be easily applied, and is less invasive. Clomiphene citrate is the most commonly used for ovulation induction, which is cheaper and has a lower incidence of multiple pregnancies. Controlled ovarian hyperstimulation with recombinant follicle stimulating hormone and IUI has a higher incidence of pregnancy rates in an ovulation, unexplained and mild male factor infertility cases. Data including age, BMI, smoking, the duration of infertility, the type of infertility, total motile sperm count (TMSS) of inseminated material and sperm morphology, antral follicle count, number of developed follicles and endometrial thickness on HCG day will be recorded. On the 2nd or 3rd day of the cycle, the patient will be randomized into two groups. Group 1 (rFSH: n=127, 75 IU FSH/day), and Group 2 (clomiphene citrate 100 mg/day for 5 days following by 75 IU FSH/day; n=127). Human chorionic gonadotropin (hCG) will be used for trigger when the dominant follicle's diameter reaches 17-18mm for ovulation. Thirty-six hours after the hCG injection, single IUI will be performed by using the fresh sperm obtained by the density gradient method with a soft catheter in the dorsolithotomy position under ultrasound guidance. The patient will be kept supine position after the procedure for 15 minutes. After IUI, sexual intercourse will be recommended for three days. Intravaginal progesterone (LUTINUS® 100 mg vaginal tablet, Ferring GmbH Wittland/Kiel/Germany) to both groups will be used once a day after insemination for luteal phase support. Clinical pregnancy rates will be recorded by performing a blood test for on the 15th day after the procedure. The aim of study is to evaluate the results of two different protocols for ovulation induction during IUI cycles. All patients undergo IUI cycles are randomly divided in to two groups. the first group is recombinant follicle stimulating hormone and the second group is the combination of recombinant follicle stimulating hormone with clomiphene citrate

Interventions

clinical pregnancy rates

DRUGRecombinant Follicle Stimulating Hormone and Clomiphene Citrate

clinical pregnancy rates

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* 18-40 years old female * Unexplained infertility * Regular menstrual cycle * Bilateral tubal patency in HSG and normal uterine cavity * Total motile sperm count greater than 10 million/ml

Exclusion criteria

* History of ovarian surgery * Uncorrected uterine pathology * Other endocrine diseases (thyroid, prolactin, hypogonadotropic hypogonadism) * Presence of a cyst greater than 10 mm on USG in 2-3 days of the period * Stage 3-4 endometriosis * TMSS \< 5 million/ml on the insemination day * Conditions where rFSH and clomiphene citrate are contraindicated

Design outcomes

Primary

MeasureTime frameDescription
Rate of clinical pregnancyday 15after iui betahcg levels blood sampling

Secondary

MeasureTime frameDescription
Rate of ongoing pregnancyMonths 3Ongoing pregnancy rates 3 months after iui

Countries

Turkey (Türkiye)

Contacts

Primary ContactPinar Ozcan, MD,PhD
drpinarozcan@hotmail.com+902124531700

Outcome results

None listed

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