Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF)

Study Overview
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Brief Summary
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Prospective, open, randomised, parallel, multicentre, two arm trial comparing a new form of luteal support (S.C.) to an approved comparator (vaginal gel).

Official Title
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Efficacy and Tolerability of Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF)

Conditions
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In Vitro Fertilization

Intervention / Treatment
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* Drug: Progesterone
* Drug: Progesterone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18- 42 (upon starting COH); BMI <30 kg/m2; <3 prior ART cycles (IVF, ICSI and related procedures); Baseline (day 2-3 of cycling) FSH <15 IU/L and E2 <80 pg/mL; Normal uterine cavity as per recent hysterosalpingogram, sonohysterogram or hysteroscopic exam (i.e. no polyp or protruding sub-mucosal fibroid); At least 3 retrieved oocytes; Patient has given written informed consent. Exclusion Criteria: Intramural uterine fibroids that distort the uterine cavity or polyps >1 cm; Stage III or IV endometriosis (endometriomas); Hydrosalpinx; History of past poor response to COH resulting in canceling ART; Use of thawed/donated oocytes; Use of thawed/donated embryos; Patients affected by pathologies associated with any contraindication of being pregnant; Hypersensitivity to study medication; Uncontrolled adrenal or thyroid dysfunction; Undiagnosed vaginal bleeding; History of arterial disease; Patients with hepatic impairment; Neoplasias (current) or history of neoplasia that may be responsive to progesterone; High grade cervical dysplasia; Active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders; History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages wherein pregnancy developed to a minimum of a gestational sac on TVUS; Participation in a concurrent clinical trial or another trial within the past 2 months; Use of concomitant medications that might interfere with the study evaluation; Pre-implantation genetic diagnosis/screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Progesterone SC<br> | Drug: Progesterone<br>* 25 mg, s.c., once à day<br>|
| Active Comparator: Progesterone Vaginal gel<br> | Drug: Progesterone<br>* 90 mg, vaginally, once à day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing Pregnancy Rate at the End of the Study |  | 10 weeks after treatment start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery Rate and Live Birth Rate |  | nearly 9 month after treatment start | 
| Implantation Rate | Implantation rate was defined as the mean of the total number of gestational sacs seen divided by the total number of embryos transferred. Values are reported as a percentage. | Four to five weeks after oocytes retrieval | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Luteal Phase Support in IVF patients