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

NCT ID: NCT05276531

Last Updated: 2022-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2022-09-01

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.

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.

Conditions

Progesterone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

subcutaneous progesterone

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

Group Type: EXPERIMENTAL

subcutaneous progesterone

Intervention Type: DRUG

clinical pregnancy rates

vaginal progesterone

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

Group Type: ACTIVE_COMPARATOR

vaginal progesterone

Intervention Type: DRUG

clinical pregnancy rates

Interventions

subcutaneous progesterone

clinical pregnancy rates

Intervention Type: DRUG

vaginal progesterone

clinical pregnancy rates

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gurkan Kiran, MD

Role: STUDY_CHAIR

Bezmialem Vakif University

Locations

Bezmialem Vakif University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Maher MA. Luteal phase support may improve pregnancy outcomes during intrauterine insemination cycles. Eur J Obstet Gynecol Reprod Biol. 2011 Jul;157(1):57-62. doi: 10.1016/j.ejogrb.2011.03.022. Epub 2011 Apr 21.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Khosravi D, Taheripanah R, Taheripanah A, Tarighat Monfared V, Hosseini-Zijoud SM. Comparison of oral dydrogesterone with vaginal progesteronefor luteal support in IUI cycles: a randomized clinical trial. Iran J Reprod Med. 2015 Jul;13(7):433-8.

Reference Type: BACKGROUND

PMID: 26494991 (View on PubMed)

Green KA, Zolton JR, Schermerhorn SM, Lewis TD, Healy MW, Terry N, DeCherney AH, Hill MJ. Progesterone luteal support after ovulation induction and intrauterine insemination: an updated systematic review and meta-analysis. Fertil Steril. 2017 Apr;107(4):924-933.e5. doi: 10.1016/j.fertnstert.2017.01.011. Epub 2017 Feb 24.

Reference Type: BACKGROUND

PMID: 28238492 (View on PubMed)

Other Identifiers

18.10.2021-E.36477

Identifier Type: -

Identifier Source: org_study_id