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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Luteal Phase

Intervention / Treatment
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* Drug: Utrogestan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| combined progesterone group<br>patients will receive vaginal plus subcutaneous or per os progesterone | Drug: Utrogestan<br>* PROSPECTIVE STUDY<br>* Other names: PROLUTEX,VASCLOR;|
| Vaginal progesterone group<br>patients will receive vaginal progesterone | Drug: Utrogestan<br>* PROSPECTIVE STUDY<br>* Other names: PROLUTEX,VASCLOR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate | The percentage of viable embryo after 20 weeks of gestation | 9 months] | 
| Abortion rate | Loss of pregnancy up to 20 weeks of gestation | 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, PROGESTERONE