Infertility Clinical Trial
Official title:
Subcutaneous Progesterone (Prolutex) Versus Vaginal Progesterone Capsules (Progeffik) for Endometrial Preparation in Fresh Donated Oocytes Recipients: a Randomised, Prospective, Single-blind, Pilot Study
Verified date | August 2016 |
Source | Instituto Bernabeu |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | December 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 48 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Instituto Bernabeu | Alicante |
Lead Sponsor | Collaborator |
---|---|
Instituto Bernabeu |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | number of uterine contractions per minute | number of uterine contractions per minute on the day of embryo transfer | day 5 | |
Primary | ongoing pregnancy rate at 12 weeks gestation | ongoing pregnancy rate at 12 weeks gestation using subcutaneous progesterone and using vaginal progesterone capsules | 12 weeks | |
Secondary | progesterone level on the days of the transfer | progesterone level on the days of the transfer | 5 days | |
Secondary | progesterone level on biochemical pregnancy test beta-hCG | progesterone level on biochemical pregnancy test beta-hCG | 14 days | |
Secondary | endometrium thickness on the day of oocyte retrieval | endometrium thickness on the day of oocyte retrieval | 0 day | |
Secondary | endometrium thickness on the day of embryo transfer | endometrium thickness on the day of embryo transfer | 5 days | |
Secondary | endometrium morphology on the day of oocyte retrieval | endometrium morphology (trilaminar pattern and echogenicity) on the day of oocyte retrieval | 0 day | |
Secondary | endometrium morphology on the day of embryo transfer | endometrium morphology (trilaminar pattern and echogenicity) on the day of embryo transfer | 5 days | |
Secondary | implantation rate | number of embryo sacs at 4-5 weeks (by ultrasound) versus number of embryos transferred | 4-5 weeks | |
Secondary | positive biochemical pregnancy test beta- hCG rate | positive biochemical pregnancy test beta- hCG rate at 14 days | 14 days | |
Secondary | clinical pregnancy rate | rate of patients with embryo any sac with a heartbeat (by ultrasound) | 4-5 weeks | |
Secondary | miscarriage rate | miscarriage rate in patients with positive biochemical pregnancy test beta- hCG rate on day +14 | 10 weeks | |
Secondary | occurrence of side effects | occurrence of side effects associated with progesterone | day 5, day 14, 4-5 days, 10 weeks | |
Secondary | comfort in relation to the progesterone administration route | comfort in relation to the progesterone administration route | 10 weeks |
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