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Different Strategies in Frozen IVF/ICSI Cycles

Sponsor
National and Kapodistrian University of Athens (Other)
Overall Status
Completed
CT.gov ID
NCT03965949
Collaborator
Democritus University of Thrace (Other)
311
Enrollment
1
Location
5.9
Actual Duration (Months)
52.9
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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

  1. 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).

Study Design

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 :
Jun 6, 2019
Actual Primary Completion Date :
Dec 2, 2019
Actual Study Completion Date :
Dec 2, 2019

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. live birth [1 year]

    birth after 20 weeks of gestation

  2. ongoing pregnancy [3 months]

    positive heart rate after 12 weeks

  3. miscarriage [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 [3 months]

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

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Attikon University Hospital Athens Chaidari Greece 12462

Sponsors and Collaborators

  • National and Kapodistrian University of Athens
  • Democritus University of Thrace

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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
Last Update Posted:
Sep 9, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hormones

Study Results

No Results Posted as of Sep 9, 2020