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Role of Suppression of Endometriosis With Progestins Before IVF-ET

Primary Purpose

IVF, Endometriosis, Pregnancy Rate

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dienogest
leuprorelin acetate
Sponsored by
National Research Centre, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IVF

Eligibility Criteria

30 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • confirmed diagnosis of endometriosis
  • body mass index < 35 Kg/m2

Exclusion Criteria:

  • if they have been already on long-term down-regulation of the pituitary gland with GnRHa for control of endometriosis
  • liver or kidney disease
  • evidence of diminished ovarian reserve (e.g. high FSH level >12 IU/L or low AMH level <1 ng/ml).

Sites / Locations

  • Minia Infertility research unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dienogest

GnRH analogue

Arm Description

Outcomes

Primary Outcome Measures

the number of retrieved oocytes
the number of retrieved oocytes as the main concern was the effect of either GnRHa or Dienogest on ovarian responsiveness

Secondary Outcome Measures

the fertilization rate
defined as the number of zygotes with two pronuclei divided by the number of oocytes
the number of transferrable embryos
defined as the number of embryos suitable for transfer in the stimulated cycle or cryopreservation
the cost of the treatment
the cost of the treatment in Egyptian pounds including cost of pretreatment and ovarian stimulation drugs
pregnancy rate per cycle started
defined as patients with positive urinary or serum pregnancy test divided by the number of patients starting the treatment
the clinical pregnancy rate per cycle started
defined as the number of patients with at least one intrauterine gestational sac with identifiable fetal heart pulsations over the total number of patients starting the treatment
the miscarriage rate
defined as patients with identified intrauterine gestational sac without a fetal pole, or a fetal pole with no heart pulsations with no other viable fetuses over the number of patients with positive pregnancy test
patient's quality of life
patient's quality of life during the pretreatment period as assessed by the Fertility quality of life (FertiQoL) questionnaire with a range of 0 (the worst) to 100 (the best).

Full Information

First Posted
July 29, 2020
Last Updated
August 3, 2020
Sponsor
National Research Centre, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT04500743
Brief Title
Role of Suppression of Endometriosis With Progestins Before IVF-ET
Official Title
Role of Suppression of Endometriosis With Progestins Before IVF-ET: a Non-inferiority Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Centre, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This study aimed to assess the role of Dienogest pretreatment for endometriosis suppression as compared to Gonadotropin-releasing hormone agonist (GnRHa) in patients with endometriosis pursuing IVF treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IVF, Endometriosis, Pregnancy Rate, Progestins, GnRH-analogue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dienogest
Arm Type
Active Comparator
Arm Title
GnRH analogue
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dienogest
Intervention Description
Group B (n=67) who had daily oral Dienogest 2 mg/d for 3 months before starting standard long protocol for IVF
Intervention Type
Drug
Intervention Name(s)
leuprorelin acetate
Intervention Description
Group A (n=67) who had monthly depot GnRHa for 3 months before ovarian stimulation in IVF treatment (Ultra-long protocol)
Primary Outcome Measure Information:
Title
the number of retrieved oocytes
Description
the number of retrieved oocytes as the main concern was the effect of either GnRHa or Dienogest on ovarian responsiveness
Time Frame
After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
Secondary Outcome Measure Information:
Title
the fertilization rate
Description
defined as the number of zygotes with two pronuclei divided by the number of oocytes
Time Frame
After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
Title
the number of transferrable embryos
Description
defined as the number of embryos suitable for transfer in the stimulated cycle or cryopreservation
Time Frame
After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
Title
the cost of the treatment
Description
the cost of the treatment in Egyptian pounds including cost of pretreatment and ovarian stimulation drugs
Time Frame
After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
Title
pregnancy rate per cycle started
Description
defined as patients with positive urinary or serum pregnancy test divided by the number of patients starting the treatment
Time Frame
After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
Title
the clinical pregnancy rate per cycle started
Description
defined as the number of patients with at least one intrauterine gestational sac with identifiable fetal heart pulsations over the total number of patients starting the treatment
Time Frame
after women have postive pregnancy test (2 weeks after after the embryo transfer)
Title
the miscarriage rate
Description
defined as patients with identified intrauterine gestational sac without a fetal pole, or a fetal pole with no heart pulsations with no other viable fetuses over the number of patients with positive pregnancy test
Time Frame
After occurence of the clinical pregnancy (5 months after after the embryo transfer)
Title
patient's quality of life
Description
patient's quality of life during the pretreatment period as assessed by the Fertility quality of life (FertiQoL) questionnaire with a range of 0 (the worst) to 100 (the best).
Time Frame
throughout the pre-treatment with GnRHa or Dienogest as well as the induction of ovulation "through study completion, an average of 9 months"

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: confirmed diagnosis of endometriosis body mass index < 35 Kg/m2 Exclusion Criteria: if they have been already on long-term down-regulation of the pituitary gland with GnRHa for control of endometriosis liver or kidney disease evidence of diminished ovarian reserve (e.g. high FSH level >12 IU/L or low AMH level <1 ng/ml).
Facility Information:
Facility Name
Minia Infertility research unit
City
Minya
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
33784989
Citation
Khalifa E, Mohammad H, Abdullah A, Abdel-Rasheed M, Khairy M, Hosni M. Role of suppression of endometriosis with progestins before IVF-ET: a non-inferiority randomized controlled trial. BMC Pregnancy Childbirth. 2021 Mar 30;21(1):264. doi: 10.1186/s12884-021-03736-2.
Results Reference
derived

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Role of Suppression of Endometriosis With Progestins Before IVF-ET

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