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

January 31, 2024 updated by: Bezmialem Vakif University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

254

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Bezmialem Vakif University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: recombinant follicle stimulating hormone
Gonal-f® (75 I.U., Merck Serono, Darmstadt, Germany)
Drug: Recombinant Follicle Stimulating Hormone
clinical pregnancy rates
Active Comparator: recombinant follicle stimulating hormone and clomiphene citrate
Gonal-f® (75 I.U., Merck Serono, Darmstadt, Germany) Klomen® (50 mg, Koçak Farma, Tekirdag, Turkey)
Drug: Recombinant Follicle Stimulating Hormone and Clomiphene Citrate
clinical pregnancy rates

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of clinical pregnancy
Time Frame: day 15
after iui betahcg levels blood sampling
day 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of ongoing pregnancy
Time Frame: Months 3
Ongoing pregnancy rates 3 months after iui
Months 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

January 2, 2023

First Submitted That Met QC Criteria

January 2, 2023

First Posted (Actual)

January 4, 2023

Study Record Updates

Last Update Posted (Actual)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07.12.2022-E.87948

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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