Subcutaneous Progesterone Versus Vaginal Progesterone Tablets for Luteal Phase Support in In Vitro Fertilization (IVF)

Study Overview
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Brief Summary
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Prospective, open, randomized, parallel, multicenter, two-arm trial to evaluate the efficacy and tolerability of a new progesterone formulation to be used for luteal support in IVF (Progesterone-IBSA) administered subcutaneously at a daily dose of 25 mg versus Progesterone tablets administered intravaginally at 100 mg twice daily for a total dose of 200 mg.

Official Title
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Efficacy and Tolerability of Subcutaneous Progesterone (IBSA) Versus Vaginal Progesterone 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: Patient has given written informed consent; BMI < 30 kg/m2; Age 18 - 42 (upon starting COH); <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 polyps or protruding submucosal fibroids); Patients must have at least three retrieved oocytes. Exclusion Criteria: Intramural uterine fibroids that distort the uterine cavity or polyps >1 cm; Stage III or IV endometriosis (no endometriomas); Hydrosalpinges; History of past poor response to COH resulting in canceling ART; Use of thawed/donated oocytes; Use of thawed/donated embryos; Gestational carrier; Patients affected by pathologies associated with any contraindication of being pregnant; Hypersensitivity to study medication; Uncontrolled adrenal or thyroid dysfunction; History of conditions (i.e. toxic shock syndrome) that would contraindicate use of a vaginal progesterone product; History of arterial disease; Patients with hepatic impairment (liver function tests > 2x upper limits of normal); Patients with dermatologic disease; Patients with renal impairment (estimated creatinine clearance <60 mL/min/1.73 m2); Neoplasias (current) or history of neoplasia that may be responsive to progesterone; High grade cervical dysplasia; 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 in 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, once a day, SC<br>|
| Active Comparator: Progesterone Tablets<br> | Drug: Progesterone<br>* 100 mg, twice a day, vaginally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing Pregnancy Rate |  | 10 weeks after treatment start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation Rate | Implantation rate was defined as the number of gestational sacs divided by the number of embryos transferred (%). This value was calculated for all the patients who had at least one embryo transferred. | 4-5 weeks after treatment start | 
| Delivery Rate |  | nearly 9 months after treatment start | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Luteal support in IVF