Skip to main content
Clinical Trials/NCT03684421
NCT03684421
Unknown
Not Applicable

Clinical and Live Birth Rates After Controlled Ovarian Stimulation With the Long Antagonist Protocol Versus Classical Antagonist Protocol

Assisting Nature1 site in 1 country120 target enrollmentFebruary 15, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy, Ovarian
Sponsor
Assisting Nature
Enrollment
120
Locations
1
Primary Endpoint
Clinical Pregnancy Rate according to stimulation protocol
Last Updated
5 years ago

Overview

Brief Summary

A randomized prospective study of the evaluation of the clinical IVF results after following Long Antagonist protocol for controlled ovarian stimulation versus following classical antagonist protocol

Detailed Description

A randomized prospective study of administration of Degarelix in late luteal phase of women undergoing ovarian stimulation for IVF: Single dose of Degarelix (24mg, 16mg or 12 mg), on day 24th of previous luteal face cycle, was administered. The Clinical Pregnancy and Live Birth Rates were estimated for this group of patients, comparing to the rates of the group which followed classical antagonist protocol. The number of the formed blastocysts in each group is measured, as well.

Registry
clinicaltrials.gov
Start Date
February 15, 2017
End Date
June 30, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Assisting Nature
Responsible Party
Principal Investigator
Principal Investigator

Papanikolaou Evaggelos

Papanikolaou Evaggelos, MD, PhD

Assisting Nature

Eligibility Criteria

Inclusion Criteria

  • primary infertility
  • age 18-39 years; body mass index (BMI) 18-29kg/m2;
  • regular menstrual cycle of 26-35days,
  • presumed to be ovulatory;
  • early follicular- phase serum concentration of FSH within normal limits (1-12 IU/l).

Exclusion Criteria

  • women with diabetes and other metabolic disease
  • women with heart disease, QT prolongation,heart failure
  • elevated liver enzymes, liver failure, hepatitis
  • women with inflammatory or autoimmune disease
  • abnormal karyotype;
  • polycystic ovarian syndrome,
  • endometriosis stage III/IV;
  • history of being a 'poor responder',
  • defined as \>20 days of gonadotrophin in a previous stimulation cycle, or any previous cancellation of a stimulation cycle due to limited follicular response, or development of less than 4 follicles 15 mm in a previous stimulation cycle; history of recurrent miscarriage; severe OHSS in a previous stimula- tion cycle or any contraindication for the use of gonadotrophins.

Outcomes

Primary Outcomes

Clinical Pregnancy Rate according to stimulation protocol

Time Frame: 6 weeks to 42 weeks after embryo transfer

Clinical Pregnancy Rate according to stimulation protocol

Number of formed blastocysts

Time Frame: 5 days after the OPU day

The number of the formed blastocysts in each group

Secondary Outcomes

  • Live Birth Rate according to stimulation protocol(6 weeks to 42 weeks after embryo transfer)

Study Sites (1)

Loading locations...

Similar Trials