Subcutaneous Progesterone Versus Vaginal Progesterone for Endometrial Preparation in Fresh Donated Oocytes Recipients

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Randomised, prospective, investigator-blinded, controlled, single-centre study to assess the impact on the ongoing pregnancy rate with the use of two progesterones with different administration routes, in recipients of fresh embryos from donor oocytes, undergoing endometrial preparation for fresh embryo transfer.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Bernabeu
• Treatments: Progesterone

Criteria

Inclusion Criteria:

• Female, aged from 18 to 49 years (both inclusive)

• Woman who wishes to become pregnant

• Endometrial thickness greater 7 mm on the day of patient randomisation to one of the progesterone groups

• Six or more donor retrieved oocytes

• Patient programmed for fresh embryo transfer on day +5 of embryo culture

• BMI lower than 30 Kg/m2

• Infertility that justifies treatment with donor oocytes

• Male with no known karyotype alterations

• Semen by ejaculation from either the partner or from a bank

• Uterus able to support embryo implantation and pregnancy

• Absence of pregnancy before starting the embryo transfer cycle

• Has given prior written consent

Exclusion Criteria:

• - Important systemic diseases, endocrine-metabolic abnormalities involving the pituitary, thyroid, adrenals, pancreas, liver or kidney.

• HIV, HBV or HCV seropositivity

• Undiagnosed vaginal bleeding

• Pregnancy, breastfeeding or any contraindication to becoming pregnant

• Malformation of sexual organs incompatible with pregnancy

• Known allergy to progesterone preparations or their excipients

• Current dependence on alcohol, drugs or psychotropic medication

• Concurrent participation in another study

• Concomitant medication that could interfere with the study medication: different hormonal treatments used in the study, except thyroid hormones, antipsychotics, anxiolytics, hypnotics, sedatives, chronic treatment with prostaglandin inhibitors