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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02363127
• Other study ID #: BER-PRO-2014-01
• Status: Completed
• Phase: Phase 4
• First received: February 9, 2015
• Last updated: March 1, 2017
• Start date: February 2015
• Est. completion date: December 2016

Study information

• Verified date: August 2016
• Source: Instituto Bernabeu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Exploratory study with a control group treated according to our Service's usual therapeutic regimen for the transfer of embryos with donor oocytes.

The controlled ovarian stimulation protocol in oocyte donors is always calculated according to the standard protocol at the Bernabeu Institute. Endometrial preparation will be carried out following the standard protocol of the Bernabeu Institute as follows: the oestrogen will be administered transdermally and patients with maintained ovarian function undergo medical hypophysectomy with depot GnRH agonists administered in the mid-luteal phase of the previous cycle.

On the day of oocyte retrieval, the patient will be randomised: Group A will be administered subcutaneous progesterone 25 mg/day (Prolutex), and Group B will be administered vaginal progesterone in capsules 200 mg/3 times a day (Progeffik).

The embryo transfer will be performed on day 5 of the embryo culture (Day +5). A biochemical pregnancy test beta- hCG and the P4 analysis will be performed 14 days after oocyte retrieval.

All the cycles will be monitored according to the Department's standard criteria, using transvaginal ultrasound to assess embryonic development and endometrial thickness, as well as analytical controls.

The study will be blinded to the investigator. The evaluating professionals will not know if the subject has been administered vaginal progesterone or subcutaneous progesterone. The medication will be delivered by a person who does not participate in the evaluations and who is dedicated to group assignment, to data centralisation, and to delivering the medication.

The aim of this study is to determine if the ongoing pregnancy rate in patients undergoing a fresh embryo transfer cycle with donor oocytes is affected by the progesterone administration route.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• subcutaneous progesterone
subcutaneous progesterone 25 mg/day
• vaginal progesterone
vaginal progesterone in capsules 200 mg/3 times a day

Locations

Country	Name	City	State
Spain	Instituto Bernabeu	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Bernabeu

Country where clinical trial is conducted

Spain, 

Outcome

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