Fertility Agents, FemalePhase 2NCT00398229
hCG Supplementation in Frozen-Thawed Embryo Transfer Cycle
A Phase 2 study testing s.c. human chorionic gonadotropin (Ovitrelle) in people with Fertility Agents, Female, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The implantation rate after frozen-thawed embryo transfer cycles depends mostly on the receptivity of the endometrium and the embryo quality.The effects of human chorionic gonadotropins (hCG) on the endometrium have been investigated for several years. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Fertility Agents, Female
- What is being tested?
- s.c. human chorionic gonadotropin (Ovitrelle)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2006to May 2008
- Phase
- Phase 2
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- all women on frozen-thawed embryo-transfer cycle
Who cannot join
- any allergy to injection of human chorionic gonadotropin before
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Benefit of Human Chorionic Gonadotropin (hCG) Supplementation Throughout the Secretory Phase of Frozen-Thawed Embryo Transfer Cycles
The implantation rate after frozen-thawed embryo transfer cycles depends mostly on the receptivity of the endometrium and the embryo quality.The effects of human chorionic gonadotropins (hCG) on the endometrium have been investigated for several years. hCG was shown to up-regulate gene expression during the differentiation of human endometrial stromal cells into decidua. The aim of our study was to assess the benefit of hCG supplementation throughout the secretory phase of artificial frozen-thawed embryo transfer cycles.
- Conditions
- Fertility Agents, Female
- Being tested
- s.c. human chorionic gonadotropin (Ovitrelle)
- Keywords
- In-Vitro Fertilization, human chorionic gonadotropin, frozen-thawed embryo transfer, implantation rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
s.c. human chorionic gonadotropin (Ovitrelle)Drug
S.C. Ovitrelle 250 mcg once
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | receiving hCG injection Receives: Drug: s.c. human chorionic gonadotropin (Ovitrelle) |
| B | Placebo comparator | Not described Receives: Drug: s.c. human chorionic gonadotropin (Ovitrelle) |
What is being measured
The primary outcome is the main question the study is designed to answer.
implantation rate
Measured: 4 weeks
pregnancy rate
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2006 (estimated)
- Study startNov 2006
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility Agents, FemaleStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Assaf Ben-Meir, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398229
- Sponsor's protocol ID
- freezehcg-HMO-CTIL
- Status last verified
- Nov 2007
- First submitted
- 9 Nov 2006
- Last updated
- 1 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefit of Human Chorionic Gonadotropin (hCG) Supplementation Throughout the Secretory Phase of Frozen-Thawed Embryo Transfer Cycles
- ClinicalTrials.gov ID
- NCT00398229
- Acronym / sponsor ID
- freezehcg-HMO-CTIL
- Conditions
- Fertility Agents, Female
- Keywords
- In-Vitro Fertilization, human chorionic gonadotropin, frozen-thawed embryo transfer, implantation rate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Nov 2006
- Study completion
- May 2008 (actual)
- First posted
- 10 Nov 2006 (estimated)
- 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.
The implantation rate after frozen-thawed embryo transfer cycles depends mostly on the receptivity of the endometrium and the embryo quality.The effects of human chorionic gonadotropins (hCG) on the endometrium have been investigated for several years. hCG was shown to up-regulate gene expression during the differentiation of human endometrial stromal cells into decidua. The aim of our study was to assess the benefit of hCG supplementation throughout the secretory phase of artificial frozen-thawed embryo transfer cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: s.c. human chorionic gonadotropin (Ovitrelle)receiving hCG injection |
| B | Placebo comparator | Drug: s.c. human chorionic gonadotropin (Ovitrelle) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all women on frozen-thawed embryo-transfer cycle
Key exclusion criteria (1 listed)
- any allergy to injection of human chorionic gonadotropin before
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 |
|---|---|---|
| s.c. human chorionic gonadotropin (Ovitrelle)S.C. Ovitrelle 250 mcg once | Drug | A, B |
Primary outcome
implantation rate
Time frame: 4 weeks
pregnancy rate
Time frame: 4 weeks
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 1 Jan 2009.
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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.
Assaf Ben-Meir, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing s.c. human chorionic gonadotropin (Ovitrelle) in people with Fertility Agents, Female, run by Hadassah Medical Organization at 1 site in Israel.
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 1 Jan 2009. 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 Israel. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
implantation rate (time frame: 4 weeks). The study lists 2 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 1 Jan 2009.