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Clinical and Live Birth Rates After Following Long Antagonist Protocol Versus Classical Antagonist Protocol

A

Assisting Nature

Status

Unknown

Conditions

Pregnancy, Ovarian

Treatments

Diagnostic Test: Pregnancy Rate

Study type

Observational

Funder types

Other

Identifiers

NCT03684421
Long-Ant-vs-Ant-AN006

Details and patient eligibility

About

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

Full 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.

Enrollment

120 estimated patients

Sex

Female

Ages

18 to 39 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

120 participants in 2 patient groups

Long Antagonist Protocol
Description:
Clinical pregnancy rate and live birth rates of patients who followed Long Antagonist Protocol for COS
Treatment:
Diagnostic Test: Pregnancy Rate
Classical Antagonist Protocol
Description:
Clinical pregnancy rate and live birth rates of patients who followed Classical Antagonist Protocol for COS
Treatment:
Diagnostic Test: Pregnancy Rate

Trial contacts and locations

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Central trial contact

Evaggelos Papanikolaou, MD,PhD

Data sourced from clinicaltrials.gov

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