Different Strategies in Frozen IVF/ICSI Cycles

NCT03965949 | Completed DMC

• 1 other identifier: HRT001
• Study Type: observational
• Target: 311
• Locations: 1 country
• Sites: 1

Brief Summary

In the absence of robust contemporary data, investigators decided to perform a multicenter cohort study of various IVF centers, to compare the different modalities used for pregnancy rates following frozen-thawed embryo transfer (FET) treatment cycles in normoovulatory patients undergoing IVF/ICSI.

Conditions

Pregnancy Rates

Outcome Measures

Primary Outcomes (3)

• live birth

  birth after 20 weeks of gestation

  1 year

• ongoing pregnancy

  positive heart rate after 12 weeks

  3 months

• miscarriage

  pregnancy loss up to 20 weeks of gestation

  6 months

Secondary Outcomes (1)

• biochemical pregnancy (positive β-hCG), multiple, ectopic and clinical pregnancy rates

  3 months

Study Arms (4)

Group 1

Natural cycle, spontaneous ovulation or ovulation triggering by exogenous hCG without luteal support

Drug: Hormone Replacement cycle 1

Group 2

Natural cycle, spontaneous ovulation or ovulation triggering by exogenous hCG with luteal support (progesterone)

Drug: Hormone Replacement cycle 1

Group 3

Hormone Replacement cycle (cyclacur) plus GnRHa suppression with luteal support (progesterone)

Drug: Hormone Replacement cycle 2

Group 4

Hormone Replacement cycle (cyclacur) without GnRHa suppression with luteal support (progesterone)

Drug: Hormone Replacement cycle 2

Interventions

Hormone Replacement cycle 1 DRUG

Hormone Replacement cycle (cyclacur) without GnRHa suppression with luteal support (progesterone)

Group 1; Group 2

Hormone Replacement cycle 2 DRUG

Hormone Replacement cycle with GnRHa suppression

Group 3; Group 4

Eligibility Criteria

• Age: 25 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Following clinical evaluation along with previous medical and reproductive history, participants will be categorized according to the subfertility factor and further demographic parameters (age, Body Mass Index (BMI), smoking status, basal FSH levels, parity, antral follicle count (AFC) in the fresh cycle, type (primary/secondary) and duration of subfertility and number of unsuccessful IVF/ICSI attempts (fresh and/or frozen) will be recorded along with the respective hormonal profiles.

You may qualify if:

• age 25-39 years, BMI ≤ 35 and ≥ 19, normo-ovulatory patients and basal FSH ≤11 mIU/mL. Definition of expected normal ovarian response will be based primarily on antral follicle count (AFC) between 6-14.

You may not qualify if:

• history of more than three previous unsuccessful IVF/ICSI cycles, FSH \> 12 mIU/mL, BMI \>35 or \<19, poor ovarian response according to the 2011 Bologna criteria, PCOS patients according to the Rotterdam criteria, history of untreated autoimmune, endocrine or metabolic disorders, history of pathology affecting the endometrial cavity and/or receptivity and clinical and/or laboratory markers of hereditary or acquired thrombophilia that complied to the standard protocols of each Unit and patients without embryo after thawing.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead
• Democritus University of Thrace: collaborator

Study Sites (1)

Attikon University Hospital

Athens, Chaidari, 12462, Greece

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Obstetrics Gynaecology

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 29, 2019
• Study Start: June 6, 2019
• Primary Completion: December 2, 2019
• Study Completion: December 2, 2019
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

GR (1)