Different Strategies in Frozen IVF/ICSI Cycles

NCT ID: NCT03965949

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 311 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-06
• Study Completion Date: 2019-12-02

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.

Detailed Description

In general, the type of FET protocol for each patient is selected by the attending physicians at their own discretion. In all centers, patients with ovulatory cycles are typically prescribed an NC-FET or mNC-FET, whereas patients with oligomenorrhoea or amenorrhoea are prescribed an artificial cycle to prepare the endometrium for FET.

Ovarian stimulation protocol

1. The antagonist protocol

2. The long 21 /2 agonist protocol Laboratory technique

a. IVF or b. ICSI Embryo freezing using only vitrification will be performed in days 3 or 5/6. Embryo transfer will be conducted at days 3 or 5/6. The maximum number of embryos transferred will be two, as in accordance to the Hellenic legislation.

The following modalities will be analyzed, patients with:

1. Natural cycle, spontaneous ovulation or ovulation triggering by exogenous hCG without luteal support (Group 1)

2. Natural cycle, spontaneous ovulation or ovulation triggering by exogenous hCG with luteal support (progesterone) (Group 2)

3. Hormone Replacement cycle (cyclacur) plus GnRHa suppression with luteal support (progesterone) (Group 3)

4. Hormone Replacement cycle (cyclacur) without GnRHa suppression with luteal support (progesterone) (Group 4)

Of note, the conversion between different supplementation methods may be testimated as follows: 0.75 mg of micronised estradiol (oral administration) = 1.25 g of estradiol gel (transdermal administration) = 1 mg of estradiol valerate (oral or vaginal adminstration).

Conditions

Pregnancy Rates

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Group 1

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

Hormone Replacement cycle 1

Intervention Type: DRUG

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

Group 2

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

Hormone Replacement cycle 1

Intervention Type: DRUG

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

Group 3

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

Hormone Replacement cycle 2

Intervention Type: DRUG

Hormone Replacement cycle with GnRHa suppression

Group 4

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

Hormone Replacement cycle 2

Intervention Type: DRUG

Hormone Replacement cycle with GnRHa suppression

Interventions

Hormone Replacement cycle 1

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

Intervention Type: DRUG

Hormone Replacement cycle 2

Hormone Replacement cycle with GnRHa suppression

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Democritus University of Thrace

OTHER

Sponsor Role: collaborator

National and Kapodistrian University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Siristatidis Charalampos, MD, PhD

Associate Professor in Obstetrics Gynaecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Attikon University Hospital

Athens, Chaidari, Greece

Countries

Greece

Other Identifiers

HRT001

Identifier Type: -

Identifier Source: org_study_id