InfertilityIVM vs IVFNCT00867763
In Vitro Maturation With in Vitro Fertilization (IVF) Compared to Mild in Vitro Fertilization
A study testing In vitro maturation and in vitro fertilization and Low doses of gonadotropin stimulation. in people with Infertility, run by Batzofin Fertility Services at 2 sites in United States.
Trial summary
Methods of infertility treatment may involve in vitro fertilization or IVF. Though effective, IVF is complex and expensive. Methods using no gonadotropin hormone stimulation of the ovaries are being compared to mild stimulation doses. Read more about this study
- Who is it for?
- Ages 21 to 41 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- In vitro maturation and in vitro fertilization and Low doses of gonadotropin stimulation.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,440 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2009to Jun 2012
- Phase
- Interventional
- 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 21 to 41 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Under age 42 female, normal uterine cavity, BMI 18-34kg/m2,
Who cannot join
- Donor eggs, donor sperm, myoma over 5 cm
- Current hydrosalpinx, abnormal uterine cavity.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Batzofin Fertilty Services
New York, New York, 10016
BFS
New York, New York
About this study
Official title: Clinical Research Study on in Vitro Maturation With IVF Compared to Mild Stimulation IVF
Methods of infertility treatment may involve in vitro fertilization or IVF. Though effective, IVF is complex and expensive. Methods using no gonadotropin hormone stimulation of the ovaries are being compared to mild stimulation doses. The goal of the research is to determine which of these if more suitable as a low cost approach for varying individual patients.
Read the detailed description
Low cost environment is utilized, but fees are charged.
- Conditions
- Infertility
- Being tested
- In vitro maturation and in vitro fertilization, Low doses of gonadotropin stimulation.
- Keywords
- Polycystic ovaries,, Tubal occlusion, Unexplained infertility, Low ovarian reserve, Male factor infertility
- Medical subject headings
- Infertility, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In vitro maturation and in vitro fertilizationProcedure or surgery
Also called assisted reproduction
No gonadotropin, eggs harvested early
Low doses of gonadotropin stimulation.Procedure or surgery
Also called Assisted reproduction, IVF.
Gonadotropin followed by conventional IVF
| Study group | Role | What they receive |
|---|---|---|
| IVM | Experimental | Early egg retrieval, in vitro maturation, then IVF Receives: Procedure: In vitro maturation and in vitro fertilization |
| Mild IVF | Active comparator | Mild gonadotropin and conventional IVF Receives: Procedure: Low doses of gonadotropin stimulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost effectiveness
Measured: two years
Secondary outcomes (1)
Ongoing pregnancy rates per cycle
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 posted24 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2011 (estimated)
- Study completionJun 2012 (estimated)
Why it stopped: investigator changed location, requires new training effort
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1,440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Batzofin Fertility Services
- Sponsor type
- University, hospital or other
- Investigators
- Joe B Massey, MD, Principal investigator, Batzofin Fertility Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867763
- Sponsor's protocol ID
- 2939
- Acronym
- IVM vs IVF
- Status last verified
- Mar 2009
- First submitted
- 23 Mar 2009
- Last updated
- 11 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Son WY, Chung JT, Herrero B, Dean N, Demirtas E, Holzer H, Elizur S, Chian RC, Tan SL. Selection of the optimal day for oocyte retrieval based on the diameter of the dominant follicle in hCG-primed in vitro maturation cycles. Hum Reprod. 2008 Dec;23(12):2680-5. doi: 10.1093/humrep/den332. Epub 2008 Sep 4.
PubMed 18775885Son WY, Chung JT, Demirtas E, Holzer H, Sylvestre C, Buckett W, Chian RC, Tan SL. Comparison of in-vitro maturation cycles with and without in-vivo matured oocytes retrieved. Reprod Biomed Online. 2008 Jul;17(1):59-67. doi: 10.1016/s1472-6483(10)60294-5.
PubMed 18616892
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research Study on in Vitro Maturation With IVF Compared to Mild Stimulation IVF
- ClinicalTrials.gov ID
- NCT00867763
- Acronym / sponsor ID
- IVM vs IVF / 2939
- Conditions
- Infertility
- Keywords
- Polycystic ovaries,, Tubal occlusion, Unexplained infertility, Low ovarian reserve, Male factor infertility
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: investigator changed location, requires new training effort
- Enrolment
- 1,440 participants (estimated)
- Lead sponsor
- Batzofin Fertility ServicesUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 24 Mar 2009 (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.
Methods of infertility treatment may involve in vitro fertilization or IVF. Though effective, IVF is complex and expensive. Methods using no gonadotropin hormone stimulation of the ovaries are being compared to mild stimulation doses. The goal of the research is to determine which of these if more suitable as a low cost approach for varying individual patients.
Detailed description
Low cost environment is utilized, but fees are charged.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVM | Experimental | Procedure: In vitro maturation and in vitro fertilizationEarly egg retrieval, in vitro maturation, then IVF |
| Mild IVF | Active comparator | Procedure: Low doses of gonadotropin stimulation.Mild gonadotropin and conventional IVF |
Who may qualify
- Ages
- 21 to 41 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Under age 42 female, normal uterine cavity, BMI 18-34kg/m2,
Key exclusion criteria (2 listed)
- Donor eggs, donor sperm, myoma over 5 cm
- Current hydrosalpinx, abnormal uterine cavity.
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 |
|---|---|---|
| In vitro maturation and in vitro fertilizationAlso: assisted reproductionNo gonadotropin, eggs harvested early | Procedure or surgery | IVM |
| Low doses of gonadotropin stimulation.Also: Assisted reproduction, IVF.Gonadotropin followed by conventional IVF | Procedure or surgery | Mild IVF |
Primary outcome
Cost effectiveness
Time frame: two years
1 secondary outcome
Ongoing pregnancy rates per cycle
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2010.
- Background: PubMed 18775885Son WY, Chung JT, Herrero B, Dean N, Demirtas E, Holzer H, Elizur S, Chian RC, Tan SL. Selection of the optimal day for oocyte retrieval based on the diameter of the dominant follicle in hCG-primed in vitro maturation cycles. Hum Reprod. 2008 Dec;23(12):2680-5. doi: 10.1093/humrep/den332. Epub 2008 Sep 4.
- Background: PubMed 18616892Son WY, Chung JT, Demirtas E, Holzer H, Sylvestre C, Buckett W, Chian RC, Tan SL. Comparison of in-vitro maturation cycles with and without in-vivo matured oocytes retrieved. Reprod Biomed Online. 2008 Jul;17(1):59-67. doi: 10.1016/s1472-6483(10)60294-5.
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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.
Joe B Massey, MD principal investigator
Batzofin Fertility Services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In vitro maturation and in vitro fertilization and Low doses of gonadotropin stimulation. in people with Infertility, run by Batzofin Fertility Services at 2 sites in United States.
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 2 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: paused, as of the sponsor's last update on 11 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Results are not available in the source record.
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?
Cost effectiveness (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00867763, which also lists 2 linked publications.
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 11 Aug 2010.