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Completed

NCT Number: NCT03965949

Different Strategies in Frozen IVF/ICSI Cycles

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.

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Key information

Conditions

Age range

25 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

Attikon University Hospital

Athens, Chaidari, 12462, Greece

About this study

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

  • The antagonist protocol
  • 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:

  • Natural cycle, spontaneous ovulation or ovulation triggering by exogenous hCG without luteal support (Group 1)
  • Natural cycle, spontaneous ovulation or ovulation triggering by exogenous hCG with luteal support (progesterone) (Group 2)
  • Hormone Replacement cycle (cyclacur) plus GnRHa suppression with luteal support (progesterone) (Group 3)
  • 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hormone Replacement cycle 1

Drug

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

Hormone Replacement cycle 2

Drug

Hormone Replacement cycle with GnRHa suppression

Primary outcomes

  1. live birth

    Time frame: 1 year

    birth after 20 weeks of gestation

  2. ongoing pregnancy

    Time frame: 3 months

    positive heart rate after 12 weeks

  3. miscarriage

    Time frame: 6 months

    pregnancy loss up to 20 weeks of gestation

Secondary outcomes

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

    Time frame: 3 months

    positive β-hCG, multiple, ectopic and clinical pregnancy rates

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Collaborators

  • Democritus University of Thrace

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 29, 2019
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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