NCT02363127

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 3, 2017

Status Verified

August 1, 2016

Enrollment Period

1.7 years

First QC Date

February 9, 2015

Last Update Submit

March 1, 2017

Conditions

Infertility

Keywords

Reproductive TechniquesInfertilityReproductive Techniques Assisted

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • progesterone level on the days of the transfer

    5 days

  • progesterone level on biochemical pregnancy test beta-hCG

    14 days

  • endometrium thickness on the day of oocyte retrieval

    0 day

  • endometrium thickness on the day of embryo transfer

    5 days

  • endometrium morphology on the day of oocyte retrieval

    0 day

  • +7 more secondary outcomes

Other Outcomes (1)

  • number of uterine contractions per minute

    day 5

Study Arms (2)

Prolutex

EXPERIMENTAL

Subcutaneous progesterone

Drug: subcutaneous progesterone

Progeffik

ACTIVE COMPARATOR

Vaginal progesterone

Drug: vaginal progesterone

Interventions

subcutaneous progesteroneDRUG

subcutaneous progesterone 25 mg/day

Also known as: Protulex
Prolutex
vaginal progesteroneDRUG

vaginal progesterone in capsules 200 mg/3 times a day

Also known as: Progeffik
Progeffik

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Bernabeu

Alicante, Alicante, 03016, Spain

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Joanquin Llacer, Ph

    Instituto Bernabeu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gynaecologist. Reproductive Medicine Specialist at Instituto Bernabeu

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 13, 2015

Study Start

February 1, 2015

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

March 3, 2017

Record last verified: 2016-08

Locations

ES(1)