Role of Suppression of Endometriosis With Progestins Before IVF-ET

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

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis; IVF; Pregnancy Rate; Progestins; GnRH-analogue
• Intervention / Treatment: Drug: Dienogest; Drug: leuprorelin acetate

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt
    • Minia Infertility research unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dienogest	Drug: Dienogest; Group B (n=67) who had daily oral Dienogest 2 mg/d for 3 months before starting standard long protocol for IVF
Active Comparator: GnRH analogue	Drug: leuprorelin acetate; Group A (n=67) who had monthly depot GnRHa for 3 months before ovarian stimulation in IVF treatment (Ultra-long protocol)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the fertilization rate	defined as the number of zygotes with two pronuclei divided by the number of oocytes	After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
the number of transferrable embryos	defined as the number of embryos suitable for transfer in the stimulated cycle or cryopreservation	After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
the cost of the treatment	the cost of the treatment in Egyptian pounds including cost of pretreatment and ovarian stimulation drugs	After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
pregnancy rate per cycle started	defined as patients with positive urinary or serum pregnancy test divided by the number of patients starting the treatment	After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
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	after women have postive pregnancy test (2 weeks after after the embryo transfer)
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	After occurence of the clinical pregnancy (5 months after after the embryo transfer)
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).	throughout the pre-treatment with GnRHa or Dienogest as well as the induction of ovulation "through study completion, an average of 9 months"

Collaborators and Investigators

• Sponsor: National Research Centre, Egypt

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Fertility Agents, Female; Fertility Agents; Contraceptives, Oral, Hormonal; Contraceptive Agents, Male; Leuprolide; Dienogest
• Other Study ID Numbers: Dienogest before IVF

Drug and device information, study documents

• 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