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

Study Overview
=================
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

Official Title
-----------------
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

Conditions
-----------------
Infertility Unexplained

Intervention / Treatment
-----------------
* Drug: Recombinant Follicle Stimulating Hormone
* Drug: Recombinant Follicle Stimulating Hormone and Clomiphene Citrate


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
iui, ovulation induction