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

Sponsor

Bezmialem Vakif University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05276531

Collaborator

(none)

146

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Progesterone	Drug: subcutaneous progesterone Drug: vaginal progesterone	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

146 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Apr 1, 2022

Actual Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: subcutaneous progesterone PROLUTEX® 25 mg Solution for injection, IBSA Group, Lugano, Switzerland	Drug: subcutaneous progesterone clinical pregnancy rates
Active Comparator: vaginal progesterone LUTINUS® 100 mg vaginal tablets, Ferring GmbH Wittland/Kiel/Germany	Drug: vaginal progesterone clinical pregnancy rates

Arm

Intervention/Treatment

Experimental: subcutaneous progesterone

PROLUTEX® 25 mg Solution for injection, IBSA Group, Lugano, Switzerland

Drug: subcutaneous progesterone

clinical pregnancy rates

Active Comparator: vaginal progesterone

LUTINUS® 100 mg vaginal tablets, Ferring GmbH Wittland/Kiel/Germany

Drug: vaginal progesterone

clinical pregnancy rates

Outcome Measures

Primary Outcome Measures

clinical pregnancy rate [day 15]
after iui betahcg levels blood sampling

Secondary Outcome Measures

Ongoing pregnancy rate [Months 3]
Ongoing pregnancy rates 3 months after iui

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bezmialem Vakif University	Istanbul		Turkey

Sponsors and Collaborators

Bezmialem Vakif University

Investigators

Study Chair: Gurkan Kiran, MD, Bezmialem Vakif University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Bezmialem Vakif University

ClinicalTrials.gov Identifier:

NCT05276531

Other Study ID Numbers:

18.10.2021-E.36477

First Posted:

Mar 11, 2022

Last Update Posted:

Jul 20, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bezmialem Vakif University

progesterone

iui

Additional relevant MeSH terms:

Progesterone

Study Results

No Results Posted as of Jul 20, 2022