Different Strategies in Frozen IVF/ICSI Cycles

Pregnancy Rates Clinical Trial

Official title:

Impact of Different Strategies in Frozen Cycles Using HRT in Normo Responding Patients Undergoing IVF/ICSI Cycles: a Multicenter Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03965949
• Other study ID #: HRT001
• Status: Completed
• Start date: June 6, 2019
• Est. completion date: December 2, 2019

Study information

• Verified date: September 2020
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: December 2, 2019
• Est. primary completion date: December 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 42 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy Rates

Intervention

Drug:
• Hormone Replacement cycle 1
Hormone Replacement cycle (cyclacur) without GnRHa suppression with luteal support (progesterone)
• Hormone Replacement cycle 2
Hormone Replacement cycle with GnRHa suppression

Locations

Country	Name	City	State
Greece	Attikon University Hospital	Athens	Chaidari

Sponsors (2)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens	Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	live birth	birth after 20 weeks of gestation	1 year
Primary	ongoing pregnancy	positive heart rate after 12 weeks	3 months
Primary	miscarriage	pregnancy loss up to 20 weeks of gestation	6 months
Secondary	biochemical pregnancy (positive ß-hCG), multiple, ectopic and clinical pregnancy rates	positive ß-hCG, multiple, ectopic and clinical pregnancy rates	3 months