Subcutaneous progesterone ( Prolutex ) versus vaginal progesterone capsules (Progeffik) for endometrial preparation in fresh donated oocyte recipients: A prospective, randomized, single-blind, pilot trial.
- Conditions
- Infertility. Assisted Reproductive Techniques. Fresh donated oocyte recipientsMedDRA version: 17.1Level: PTClassification code 10021928Term: Infertility femaleSystem Organ Class: 10038604 - Reproductive system and breast disordersTherapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
- Registration Number
- EUCTR2014-004784-20-ES
- Lead Sponsor
- Instituto Bernabeu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
Female age between 18 and 49 years (inclusive)
Women who want pregnancy
Endometrial thickness greater than 7 mm on the randomization of the patient is made to a group of progesterone
more than 6 oocytes retrieved from the donor woman
Patient scheduled for fresh embryo transfer on day +5 embryo culture
BMI greater than 30 kg / m2
Infertility justify treatment with donor oocytes Women
Males no known alterations in karyotype
Semen ejaculation from either the partner or from bank
Uterus able to support embryo implantation and pregnancy
Absence of pregnancy before starting the cycle of embryo transfer
Have consented in writing
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Important endocrine-metabolic Systemic diseases affecting pituitary, thyroid, adrenals, pancreas, liver or kidney
Seropositivity for HIV, HBV or HCV
Undiagnosed vaginal bleeding
Pregnancy, lactation or contraindication for pregnancy
Malformations of sexual organs incompatible with pregnancy
Known allergy to preparations of progesterone or its excipients
Current dependence on alcohol, drugs or psychotropic
Concurrent participation in another study
Concomitant medication that could interfere with study medication
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Assess the impact on the rate of ongoing pregnancy at 12 weeks with the use of subcutaneous progesterone or vaginal progesterone capsules for endometrial preparation in fresh donated oocyte recipients;Secondary Objective: Serum progesterone <br>thickness and morphology of endometrium <br>implantation rate<br>rate of biochemical pregnancy beta-hCG test positive <br>clinical pregnancy rate<br> abortion rate<br> tolerability<br> progesterone comfort relative to its route of administration;Primary end point(s): rate of ongoing pregnancy at 12 weeks;Timepoint(s) of evaluation of this end point: ten weeks of progesterone treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): serum progesterone level<br> endometrial thickness and morphology<br> implantation rate<br> rate of biochemical pregnancy beta-hCG test positive <br> clinical pregnancy rate<br> abortion rate<br> tolerability<br> progesterone comfort relative to its route of administration;Timepoint(s) of evaluation of this end point: serum progesterone level on the day of transfer (day 0) and day of biochemical beta-hCG pregnancy test (+14 days)<br> thickness and morphology of endometrium on the day of oocyte collection (day 0) and day of embryo transfer (+5 days)<br> implantation rate (+14 days)<br> rates of biochemical pregnancy beta-hCG test positive (+14 days)<br> clinical pregnancy rate (4 or 5 weeks)<br> abortion rate (4 to 5 weeks)<br> tolerability (+5 days +14 days, + 4-5 weeks weeks treatment +10)<br> comfort of progesterone in relation to the route of administration (days +5, +14 days, +10 weeks of treatment)