Comparison of the Effect of Subcutaneous Progesterone and Vaginal Progesterone for Luteal Phase Support

Study Overview
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Brief Summary
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The invesigators aimed to seperate the patients,which is going to be applied IUI, to two different groups as prospective randomized controlled ;assess the efficacy of the two different way pressurised progesterone by appling intravaginal progesterone to the first group; subcutaneous to the second group.

Detailed Description
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Approxymately %10-15 of the couples who are in reproductive age ,have infertility issues. %30-40 male factor ,%40-50 female factor and %20-25 both factors 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 in infertility.IUI is accepted as the most used treatment procedure according to other assisted reproductive techniques because it has lower costs ,can be easy applied and less invasive.Luteal phase ,which is approximately 14 days,is identified as between the time of ovulation and the beginning of the menstruation period. The production of progesterone in this period,is related to the function of corpus luteum. Progesterone is used as luteal support in patients which are applied ovulation induction with gonadotropin(GND). Gonadotropin is going to be used for controlled ovarian stimulation. The treatment is going to be started on second or third day of the cycle and GND dose is going to be determined according to the patient's age, body mass index, ovary reserve and past stimulation dose answer. Treatment processed gonadotropin dose is going to be arranged according to the follicle's progress and endometrial thickness. Human chorionic gonadotropin(hCG) is going to be added to the treatment when dominant follicle's diameter reached to 17-18mm for occuring of the ovulation. Sperm obtained by density gradient method using fresh sperm 36 hours after hCG, is going to be applied to the female partner with the help of a soft catheter in the dorsalitotomy position under ultrasound guidance. The patient is going to be kept in the supine position after the procedure for 15 minutes. Each patient is going to be given a single insemination and told to resume sexual intercourse for 3 days after the procedure. Intravaginal progesterone once a day to the first group after insemination to the patients divided into two different groups with randomized controlled (LUTINUS® 100 mg vaginal tablet, Ferring GmbH Wittland/Kiel/Germany) , second group subcutaneous progesterone (PROLUTEX® 25 mg Solution for injection, IBSA Group, Lugano, Switzerland) is going to be used once a day. Clinical pregnancy rates are going to be recorded by performing a blood pregnancy test on the 15th day after the procedure. The investigators aimed to separate the patients, who are going to be applied IUI, in to two different groups as prospective randomized controlled; assess the efficacy of the two different way applied progesterone by appling intravaginal progesterone to the first group; subcutaneous to the second group.

Official Title
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Comparison of the Effect of Subcutaneous Progesterone and Vaginal Progesterone for Luteal Phase Support in Intrauterine Insemination

Conditions
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Progesterone

Intervention / Treatment
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* Drug: subcutaneous progesterone
* Drug: vaginal progesterone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Absence of follicles larger than 10 mm on basal ultrasound Endometrial thickness less than 5 mm Patients with FSH<10 IU/ml, E2<60-80 pg/ml in the blood hormone test performed on the third day of the cycle and patients with antral follicle count above 7 on ultrasound Total motile sperm count greater than 10 million/ml 18-40 years old female, 18-50 years old male Anovulation, patients diagnosed with unexplained mild male factor infertility Female partners, who's BMI<25 kg/m² Being voluntarily Exclusion Criteria: Other infertility reasons The patients who doesn't meet the criterias Refusing to attend to the research

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

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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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: subcutaneous progesterone<br>PROLUTEX® 25 mg Solution for injection, IBSA Group, Lugano, Switzerland | Drug: subcutaneous progesterone<br>* clinical pregnancy rates<br>|
| Active Comparator: vaginal progesterone<br>LUTINUS® 100 mg vaginal tablets, Ferring GmbH Wittland/Kiel/Germany | Drug: vaginal progesterone<br>* clinical pregnancy rates<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate | Ongoing pregnancy rates 3 months after iui | Months 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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progesterone, iui