Vaginal Versus Combined Use of Progesterone in Fresh IVF/ICSI Cycles

• Conditions: Luteal Phase
• Interventions: Drug: Utrogestan

• Registration Number: NCT05089383
• Lead Sponsor: University of Athens

Brief Summary

Hypothesis: the combined use of progesterone administration for luteal phase support is superior to the single route of progesterone administration in terms of pregnancy outcome parameters in women undergoing fresh IVF/ICSI cycles.

Detailed Description

In ART (IVF/ICSI), most of the studies have shown a deficiency of progesterone during the luteal phase, especially due to the use of GnRH analogs. The lack of progesterone leads to abnormal endometrial development and consequently to desynchronization between the latter and the blastocyst implantation. Therefore, it is a standard of care to use progesterone for luteal phase support after embryo transfer and during the first trimester, in case of pregnancy.

According to ESHRE guidelines, either of vaginal, oral, subcutaneous or intramuscular route is advisable.

But, until now, there is no robust evidence on the effect on pregnancy outcome of the combined route of progesterone administration compared to the standard of care (single route).

The aim of this study is to compare the effectiveness of the combined route of progesterone administration to the single route.

The study is a prospective cohort study. Participants will receive either standard treatment with single route (vaginal) progesterone administration according to the ESHRE guidelines, or combination of more than one routes of administration, that is vaginal plus oral or subcutaneous progesterone, starting afterthe fresh embryo transfer until 12 weeks of gestation or a negative pregnancy test.

Study Timeline

• Study Start: 2021-09-14
• Status Verified: 2021-10
• Study First Submitted: 2021-10-10
• Study First Submitted QC: 2021-10-10
• Last Update Submitted: 2021-10-10
• Study First Posted: 2021-10-22
• Last Update Posted: 2021-10-22
• Primary Completion: 2023-02
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 698

Inclusion Criteria

• Patients with a documented history of infertility, aged 22-40, undergoing fresh embryo transfer after IVF/ICSI, under informed consent.
• Physiological menstrual cycles (24-35 days), normal endocrine function (FSH ≤ 15 IU / ml), transvaginal ultrasound without pathological findings, free personal medical history, indication for IVF/ICSI.

Exclusion Criteria

• Endocrine or metabolic disorders, e.g., PCO (S), pathology of the uterus and/or endometrium, basal FSH levels> 15 IU / ml, major surgery in the ovaries (removal), and age <22 years and > 40 years old.
• Active pelvic inflammatory disease
• IVF/ICSI with donor eggs
• Previous participation in this trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vaginal progesterone group	Utrogestan	patients will receive vaginal progesterone
combined progesterone group	Utrogestan	patients will receive vaginal plus subcutaneous or per os progesterone

Primary Outcome Measures

Name	Time	Method
Live birth rate	9 months]	The percentage of viable embryo after 20 weeks of gestation
Abortion rate	20 weeks	Loss of pregnancy up to 20 weeks of gestation

Trial Locations

Locations (1)

National and Kapodistrian University of Athens; 🇬🇷 Athens, Attica, Greece