Pretreatment With Dienogest in Women With Endometriosis Undergoing in Vitro-fertilization After a Previous Failed Cycle

NCT04306276 | Completed FDA Drug

• 1 other identifier: DIENIVF-ENDO
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

It is generally assumed that the major causes of in vitro fertilization (IVF) failure in women with endometriosis are diminished ovarian reserve, impaired endometrial receptivity and low quality of embryos. The use of prolonged courses of hormone therapy may play an important role in the strategy of overcoming endometriosis-related infertility. The aim of this study was to evaluate the use of dienogest (DNG) before an IVF cycle in women with endometriosis undergone a previous IVF failed cycle

Conditions

Endometriosis; Endometriosis Ovary; IVF

Keywords

endometriosis; IVF

Outcome Measures

Primary Outcomes (2)

• Clinical pregnancy rate

  8 weeks

• Live birth rate after reaching 24 week's gestation

  24 weeks

Secondary Outcomes (4)

• Total gonadotropin dose administered

  During the procedure

• Number of mature oocytes collected

  During the procedure

• Number of two-pronuclear (2PN) embryos

  During the procedure

• Number of blastocysts.

  During the procedure

Study Arms (2)

Patients undergoing direct IVF

Patients directly undergo IVF without receiving previous hormonal treatment

Patients pretreated with DNG

Patients having received a three-month treatment with DNG before undergoing IVF

Drug: Dienogest 2 MG

Interventions

Dienogest 2 MG DRUG

Three-month treatment with DNG (2 mg daily; Visanne, Bayer Pharma, Germany) before IVF

Patients pretreated with DNG

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with endometriosis who previously failed one IVF cycle and all resultant frozen embryo transfer

You may qualify if:

• diagnosis of endometriosis at magnetic resonance imaging or transvaginal ultrasonography;
• one failed previous IVF cycle (including failure of frozen embryo transfer);
• basal FSH \< 14.0 IU/L;
• antimullerian hormone (AMH) blood level \>= 0.5 g/mL;
• normal thyroid-stimulating hormone and prolactin.

You may not qualify if:

• history of surgery for endometriosis;
• history of uterine or adnexal surgery;
• use of hormonal therapies for the treatment of endometriosis related pain within 6 months before IVF;
• adenomyosis (magnetic resonance imaging or transvaginal ultrasonography);
• hydrosalpinx;
• submucosal fibroids;
• body mass index (BMI) ≥ 30 kg/m2;
• severe male factor infertility (\< 5 million total motile sperm count).

Sponsors & Collaborators

• Ospedale Policlinico San Martino: lead

Study Sites (1)

IRCCS Ospedale Policlinico San Martino

Genoa, 16132, Italy

Location

MeSH Terms

Conditions

Endometriosis

Interventions

dienogest

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Fabio Barra, MD, PhD

  IRCCS Ospedale Policlinico San Martino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 12, 2020
• Study Start: January 1, 2020
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 12, 2020

Record last verified: 2020-03

Locations

IT (1)