Pregnancy RatesNCT03965949
Different Strategies in Frozen IVF/ICSI Cycles
An observational study of Pregnancy Rates, run by National and Kapodistrian University of Athens at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 25 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Rates
- What is being tested?
- Hormone Replacement cycle 1 and Hormone Replacement cycle 2
- How many people
- 311 participants
- Where
- 1 siteGreece
- Study dates
- 6 Jun 2019to 2 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Different Strategies in Frozen Cycles Using HRT in Normo Responding Patients Undergoing IVF/ICSI Cycles: a Multicenter Cohort Study
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.
Read the 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
- The antagonist protocol
- The long 21 /2 agonist protocol Laboratory technique
- 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).
- Conditions
- Pregnancy Rates
- Being tested
- Hormone Replacement cycle 1, Hormone Replacement cycle 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormone Replacement cycle 1Drug
Hormone Replacement cycle (cyclacur) without GnRHa suppression with luteal support (progesterone)
Hormone Replacement cycle 2Drug
Hormone Replacement cycle with GnRHa suppression
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Natural cycle, spontaneous ovulation or ovulation triggering by exogenous hCG without luteal support Receives: Drug: Hormone Replacement cycle 1 | |
| Group 2 | Natural cycle, spontaneous ovulation or ovulation triggering by exogenous hCG with luteal support (progesterone) Receives: Drug: Hormone Replacement cycle 1 | |
| Group 3 | Hormone Replacement cycle (cyclacur) plus GnRHa suppression with luteal support (progesterone) Receives: Drug: Hormone Replacement cycle 2 | |
| Group 4 | Hormone Replacement cycle (cyclacur) without GnRHa suppression with luteal support (progesterone) Receives: Drug: Hormone Replacement cycle 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth
birth after 20 weeks of gestation
Measured: 1 year
ongoing pregnancy
positive heart rate after 12 weeks
Measured: 3 months
miscarriage
pregnancy loss up to 20 weeks of gestation
Measured: 6 months
Secondary outcomes (1)
biochemical pregnancy (positive β-hCG), multiple, ectopic and clinical pregnancy rates
positive β-hCG, multiple, ectopic and clinical pregnancy rates
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start6 Jun 2019
- Primary completion2 Dec 2019
- Study completion2 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RatesStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Democritus University of Thrace
- Responsible party
- Principal investigator, Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965949
- Sponsor's protocol ID
- HRT001
- Status last verified
- Sep 2020
- First submitted
- 24 May 2019
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will discuss it with other authors
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different Strategies in Frozen Cycles Using HRT in Normo Responding Patients Undergoing IVF/ICSI Cycles: a Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT03965949
- Acronym / sponsor ID
- HRT001
- Conditions
- Pregnancy Rates
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Collaborators
- Democritus University of Thrace
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 2 Dec 2019 (actual)
- Study completion
- 2 Dec 2019 (actual)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- The antagonist protocol
- The long 21 /2 agonist protocol Laboratory technique
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Hormone Replacement cycle 1Natural cycle, spontaneous ovulation or ovulation triggering by exogenous hCG without luteal support |
| Group 2 | – | Drug: Hormone Replacement cycle 1Natural cycle, spontaneous ovulation or ovulation triggering by exogenous hCG with luteal support (progesterone) |
| Group 3 | – | Drug: Hormone Replacement cycle 2Hormone Replacement cycle (cyclacur) plus GnRHa suppression with luteal support (progesterone) |
| Group 4 | – | Drug: Hormone Replacement cycle 2Hormone Replacement cycle (cyclacur) without GnRHa suppression with luteal support (progesterone) |
Who may qualify
- Ages
- 25 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hormone Replacement cycle 1Hormone Replacement cycle (cyclacur) without GnRHa suppression with luteal support (progesterone) | Drug | Group 1, Group 2 |
| Hormone Replacement cycle 2Hormone Replacement cycle with GnRHa suppression | Drug | Group 3, Group 4 |
Primary outcome
live birth
Time frame: 1 year
birth after 20 weeks of gestation
ongoing pregnancy
Time frame: 3 months
positive heart rate after 12 weeks
miscarriage
Time frame: 6 months
pregnancy loss up to 20 weeks of gestation
1 secondary outcome
biochemical pregnancy (positive β-hCG), multiple, ectopic and clinical pregnancy rates
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: Undecided. Will discuss it with other authors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Rates, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
live birth (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.