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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-02-29

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.

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Detailed Description

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Conditions

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In Vitro Fertilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Progesterone SC

Group Type EXPERIMENTAL

Progesterone

Intervention Type DRUG

25 mg, once a day, SC

Progesterone Tablets

Group Type ACTIVE_COMPARATOR

Progesterone

Intervention Type DRUG

100 mg, twice a day, vaginally

Interventions

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Progesterone

25 mg, once a day, SC

Intervention Type DRUG

Progesterone

100 mg, twice a day, vaginally

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No