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Different Strategies in Frozen IVF/ICSI Cycles

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ClinicalTrials.gov Identifier: NCT03965949
Recruitment Status : Completed
First Posted : May 29, 2019
Last Update Posted : September 9, 2020
Sponsor:
Collaborator:
Democritus University of Thrace
Information provided by (Responsible Party):
Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens

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.

Condition or disease Intervention/treatment
Pregnancy Rates Drug: Hormone Replacement cycle 1 Drug: Hormone Replacement cycle 2

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).

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Study Type : Observational
Actual Enrollment : 311 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of Different Strategies in Frozen Cycles Using HRT in Normo Responding Patients Undergoing IVF/ICSI Cycles: a Multicenter Cohort Study
Actual Study Start Date : June 6, 2019
Actual Primary Completion Date : December 2, 2019
Actual Study Completion Date : December 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Group/Cohort Intervention/treatment
Group 1
Natural cycle, spontaneous ovulation or ovulation triggering by exogenous hCG without luteal support
Drug: Hormone Replacement cycle 1
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)
Drug: Hormone Replacement cycle 1
Hormone Replacement cycle (cyclacur) without GnRHa suppression with luteal support (progesterone)

Group 3
Hormone Replacement cycle (cyclacur) plus GnRHa suppression with luteal support (progesterone)
Drug: Hormone Replacement cycle 2
Hormone Replacement cycle with GnRHa suppression

Group 4
Hormone Replacement cycle (cyclacur) without GnRHa suppression with luteal support (progesterone)
Drug: Hormone Replacement cycle 2
Hormone Replacement cycle with GnRHa suppression




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   25 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965949


Locations
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Greece
Attikon University Hospital
Athens, Chaidari, Greece, 12462
Sponsors and Collaborators
National and Kapodistrian University of Athens
Democritus University of Thrace
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Responsible Party: Siristatidis Charalampos, MD, PhD, Associate Professor in Obstetrics Gynaecology, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT03965949    
Other Study ID Numbers: HRT001
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Will discuss it with other authors

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs