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

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ClinicalTrials.gov Identifier: NCT02363127
Recruitment Status : Completed
First Posted : February 13, 2015
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Joaquín Llácer, Instituto Bernabeu

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.

Condition or disease Intervention/treatment Phase
Infertility Drug: subcutaneous progesterone Drug: vaginal progesterone Phase 4

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : February 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: Prolutex
Subcutaneous progesterone
Drug: subcutaneous progesterone
subcutaneous progesterone 25 mg/day
Other Name: Protulex

Active Comparator: Progeffik
Vaginal progesterone
Drug: vaginal progesterone
vaginal progesterone in capsules 200 mg/3 times a day
Other Name: Progeffik




Primary Outcome Measures :
  1. ongoing pregnancy rate at 12 weeks gestation [ Time Frame: 12 weeks ]
    ongoing pregnancy rate at 12 weeks gestation using subcutaneous progesterone and using vaginal progesterone capsules


Secondary Outcome Measures :
  1. progesterone level on the days of the transfer [ Time Frame: 5 days ]
    progesterone level on the days of the transfer

  2. progesterone level on biochemical pregnancy test beta-hCG [ Time Frame: 14 days ]
    progesterone level on biochemical pregnancy test beta-hCG

  3. endometrium thickness on the day of oocyte retrieval [ Time Frame: 0 day ]
    endometrium thickness on the day of oocyte retrieval

  4. endometrium thickness on the day of embryo transfer [ Time Frame: 5 days ]
    endometrium thickness on the day of embryo transfer

  5. endometrium morphology on the day of oocyte retrieval [ Time Frame: 0 day ]
    endometrium morphology (trilaminar pattern and echogenicity) on the day of oocyte retrieval

  6. endometrium morphology on the day of embryo transfer [ Time Frame: 5 days ]
    endometrium morphology (trilaminar pattern and echogenicity) on the day of embryo transfer

  7. implantation rate [ Time Frame: 4-5 weeks ]
    number of embryo sacs at 4-5 weeks (by ultrasound) versus number of embryos transferred

  8. positive biochemical pregnancy test beta- hCG rate [ Time Frame: 14 days ]
    positive biochemical pregnancy test beta- hCG rate at 14 days

  9. clinical pregnancy rate [ Time Frame: 4-5 weeks ]
    rate of patients with embryo any sac with a heartbeat (by ultrasound)

  10. miscarriage rate [ Time Frame: 10 weeks ]
    miscarriage rate in patients with positive biochemical pregnancy test beta- hCG rate on day +14

  11. occurrence of side effects [ Time Frame: day 5, day 14, 4-5 days, 10 weeks ]
    occurrence of side effects associated with progesterone

  12. comfort in relation to the progesterone administration route [ Time Frame: 10 weeks ]
    comfort in relation to the progesterone administration route


Other Outcome Measures:
  1. number of uterine contractions per minute [ Time Frame: day 5 ]
    number of uterine contractions per minute on the day of embryo transfer



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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02363127


Locations
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Spain
Instituto Bernabeu
Alicante, Spain, 03016
Sponsors and Collaborators
Instituto Bernabeu
Investigators
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Principal Investigator: Joanquin Llacer, Ph Instituto Bernabeu

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Responsible Party: Joaquín Llácer, Gynaecologist. Reproductive Medicine Specialist at Instituto Bernabeu, Instituto Bernabeu
ClinicalTrials.gov Identifier: NCT02363127     History of Changes
Other Study ID Numbers: BER-PRO-2014-01
First Posted: February 13, 2015    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: August 2016

Keywords provided by Joaquín Llácer, Instituto Bernabeu:
Reproductive Techniques
Infertility
Reproductive Techniques Assisted

Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs