Role of Suppression of Endometriosis With Progestins Before IVF-ET

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04500743
• Other study ID #: Dienogest before IVF
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: August 2020
• Source: National Research Center, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: April 30, 2020
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Endometriosis
• GnRH-analogue
• IVF
• Pregnancy Rate
• Progestins

Intervention

Drug:
• Dienogest
Group B (n=67) who had daily oral Dienogest 2 mg/d for 3 months before starting standard long protocol for IVF
• leuprorelin acetate
Group A (n=67) who had monthly depot GnRHa for 3 months before ovarian stimulation in IVF treatment (Ultra-long protocol)

Locations

Country	Name	City	State
Egypt	Minia Infertility research unit	Minya

Sponsors (1)

Lead Sponsor	Collaborator
National Research Center, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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"