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

Bezmialem Vakif University

Status: Completed

Conditions: Progesterone

Treatments: Drug: vaginal progesterone; Drug: subcutaneous progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT05276531

18.10.2021-E.36477

Details and patient eligibility

About

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.

Full 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.

Enrollment: 146 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

146 participants in 2 patient groups

subcutaneous progesterone

Experimental group

Description:

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

Treatment:

Drug: subcutaneous progesterone

vaginal progesterone

Active Comparator group

Description:

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

Treatment:

Drug: vaginal progesterone