Skip to main content
OpenTrials
Completed

NCT Number: NCT04500743

Role of Suppression of Endometriosis With Progestins Before IVF-ET

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

IVF Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female GnRH-analogue Pregnancy Rate Progestins Urogenital Diseases

Age range

30 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Minia Infertility research unit

Minya, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Dienogest

Drug

Group B (n=67) who had daily oral Dienogest 2 mg/d for 3 months before starting standard long protocol for IVF

Leuprorelin Acetate

Drug

Group A (n=67) who had monthly depot GnRHa for 3 months before ovarian stimulation in IVF treatment (Ultra-long protocol)

Primary outcomes

  1. the number of retrieved oocytes

    Time frame: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)

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

Secondary outcomes

  1. the fertilization rate

    Time frame: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)

    defined as the number of zygotes with two pronuclei divided by the number of oocytes

  2. the number of transferrable embryos

    Time frame: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)

    defined as the number of embryos suitable for transfer in the stimulated cycle or cryopreservation

  3. the cost of the treatment

    Time frame: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)

    the cost of the treatment in Egyptian pounds including cost of pretreatment and ovarian stimulation drugs

  4. pregnancy rate per cycle started

    Time frame: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)

    defined as patients with positive urinary or serum pregnancy test divided by the number of patients starting the treatment

  5. the clinical pregnancy rate per cycle started

    Time frame: after women have postive pregnancy test (2 weeks after after the embryo transfer)

    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

  6. the miscarriage rate

    Time frame: After occurence of the clinical pregnancy (5 months after after the embryo transfer)

    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

  7. patient's quality of life

    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"

    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).

Sponsors and collaborators

Lead sponsor

National Research Centre, Egypt

Other

Registry information

Official study title

Role of Suppression of Endometriosis With Progestins Before IVF-ET: a Non-inferiority Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Aug 5, 2020
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.