InfertilityNCT01839136
Gametes Transfer vs. Embryo Transfer for Women Undergoing Assisted Reproductive Techniques: a Randomized Controlled Trial
A study testing Intrauterine transfer of gametes and Intrauterine transfer of embryos in people with Infertility, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Background: The cost for the treatment of infertility are limiting for the health care access, particularly if we consider that the success rate per cycle is approximately 35%. Alternative regimens for controlled ovarian stimulation (COS)have been described in the medical literature, that lead to a lower cost, fewer… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Intrauterine transfer of gametes and Intrauterine transfer of embryos
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- May 2013to Feb 2014
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women undergoing ART requiring COS, oocyte retrieval and embryo transfer at the fertility clinic of the university Hospital of the Medical School of Ribeirao Preto, University of Sao Paulo, Brazil.
- Age = 18-40 years
- BMI = 18-30 Kg/m²
- Antral follicle count (AFC) ≥ 5
- Semen concentration and progressive motility above the percentile 2.5 of the fertile men (Cooper et al. 2010): sperm concentration > 9X 10⁶/mL, and progressive motility > 28%.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Setor de Reproducao Humana do HC-FMRP-USP
Ribeirão Preto, São Paulo, 14049-900
About this study
Background: The cost for the treatment of infertility are limiting for the health care access, particularly if we consider that the success rate per cycle is approximately 35%. Alternative regimens for controlled ovarian stimulation (COS)have been described in the medical literature, that lead to a lower cost, fewer injections and less risk of adverse events, particularly ovarian hyperstimulation syndrome. Furthermore, some services report excellent results with less manipulation as possible, which reduces the cost of laboratory of human and ethically be considered less complicated once fertilization occurs in the uterus and not in vitro.
Objectives: The main objective is to compare the reproductive outcomes between intrauterine transfer of gametes (TG) and embryos (TE), the secondary objective is to estimate the average number of eggs that are raised when using an EOC reduced cost.
Methods: This study will be conducted in the area of Human Reproduction, Department of Gynecology and Obstetrics Hospital of the FMRP-USP. We will conduct an open controlled study with random allocation of the participants in a 1:1 ratio, and we plan to include 100 participants. All participants will undergo an EOC reduced cost. We will compare the chance of the treatment (TE or TG) result in a live birth and clinical pregnancy per woman allocated and to estimate the number of oocytes retrieved considering all participants.
- Conditions
- Infertility
- Being tested
- Intrauterine transfer of gametes, Intrauterine transfer of embryos
- Keywords
- Assisted Reproductive Techniques, Health Services Accessibility, Ovulation Induction, Embryo Transfer
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine transfer of gametesProcedure or surgery
Intrauterine transfer of embryosProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Intrauterine transfer of gametes | Experimental | After the oocyte retrieval, the oocytes will be selected depending on the morphology of the granular cells. The transfer will be conducted in up to 2 hours after the oocytes collection, when the semen and up to 3 oocytes will be transferred. Surplus oocytes will be cryopreserved for future use. We will use a Sydney catheter (Cook Medical Inc., Bloomington, IN, USA) coupled to a 1 mL syringe to perform the transfer. The catheter will be loaded with oocytes and semen prepared in the following sequence: 10 µL of the prepared semen, a small space of air, 20 µL of the medium containing the oocytes, another small space of air and more 10 µL of prepared semen. The catheter will be placed through the endocervical canal up to the endometrial cavity guided by transabdominal ultrasound, where the liquid will be released. We will try to place the point of the catheter 1.0-1.5cm before touching the fundus of the endometrial cavity and release the liquid slowly, in approximately 30 seconds. Receives: Procedure: Intrauterine transfer of gametes |
| intrauterine transfer of embryos | Active comparator | The oocytes will be denuded and those considered to be mature will be selected for fertilization up to the number of seven. In vitro fertilization will be performed and up to two embryos will be transferred 2-3 days after the oocyte retrieval. The other embryos will be cryopreserved for future use. We will use Sidney catheter (Cook Medical Inc.) coupled to a 1 mL syringe to perform the transfer. The catheter will be loaded with embryos in the following sequence: 10 µL of culture medium, a small space of air, 20 µL of the medium containing embryos, another small space of air, and more 10 µL of culture medium. The catheter will be placed through the endocervical canal up to the endometrial cavity, guided by transabdominal ultrasound, where the liquid will be released. We will try to place the point of the catheter 1.0-1.5cm before touching the fundus of the endometrial cavity and release the liquid slowly, in approximately 30 seconds. Receives: Procedure: Intrauterine transfer of embryos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth
Measured: 9 months
Secondary outcomes (2)
Clinical pregnancy
Measured: 2 months
Number of oocytes retrieved
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionFeb 2014
Why it stopped: Low pregnancy rates in both groups
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wellington P Martins, MD, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839136
- Sponsor's protocol ID
- CAAE: 03332812.0.0000.5440
- Status last verified
- Jun 2014
- First submitted
- 21 Apr 2013
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gametes Transfer vs. Embryo Transfer for Women Undergoing Assisted Reproductive Techniques: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01839136
- Acronym / sponsor ID
- CAAE: 03332812.0.0000.5440
- Conditions
- Infertility
- Keywords
- Assisted Reproductive Techniques, Health Services Accessibility, Ovulation Induction, Embryo Transfer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low pregnancy rates in both groups
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Feb 2014 (actual)
- First posted
- 24 Apr 2013 (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.
Background: The cost for the treatment of infertility are limiting for the health care access, particularly if we consider that the success rate per cycle is approximately 35%. Alternative regimens for controlled ovarian stimulation (COS)have been described in the medical literature, that lead to a lower cost, fewer injections and less risk of adverse events, particularly ovarian hyperstimulation syndrome. Furthermore, some services report excellent results with less manipulation as possible, which reduces the cost of laboratory of human and ethically be considered less complicated once fertilization occurs in the uterus and not in vitro.
Objectives: The main objective is to compare the reproductive outcomes between intrauterine transfer of gametes (TG) and embryos (TE), the secondary objective is to estimate the average number of eggs that are raised when using an EOC reduced cost.
Methods: This study will be conducted in the area of Human Reproduction, Department of Gynecology and Obstetrics Hospital of the FMRP-USP. We will conduct an open controlled study with random allocation of the participants in a 1:1 ratio, and we plan to include 100 participants. All participants will undergo an EOC reduced cost. We will compare the chance of the treatment (TE or TG) result in a live birth and clinical pregnancy per woman allocated and to estimate the number of oocytes retrieved considering all participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrauterine transfer of gametes | Experimental | Procedure: Intrauterine transfer of gametesAfter the oocyte retrieval, the oocytes will be selected depending on the morphology of the granular cells. The transfer will be conducted in up to 2 hours after the oocytes collection, when the semen and up to 3 oocytes will be transferred. Surplus oocytes will be cryopreserved for future use. We will use a Sydney catheter (Cook Medical Inc., Bloomington, IN, USA) coupled to a 1 mL syringe to perform the transfer. The catheter will be loaded with oocytes and semen prepared in the following sequence: 10 µL of the prepared semen, a small space of air, 20 µL of the medium containing the oocytes, another small space of air and more 10 µL of prepared semen. The catheter will be placed through the endocervical canal up to the endometrial cavity guided by transabdominal ultrasound, where the liquid will be released. We will try to place the point of the catheter 1.0-1.5cm before touching the fundus of the endometrial cavity and release the liquid slowly, in approximately 30 seconds. |
| intrauterine transfer of embryos | Active comparator | Procedure: Intrauterine transfer of embryosThe oocytes will be denuded and those considered to be mature will be selected for fertilization up to the number of seven. In vitro fertilization will be performed and up to two embryos will be transferred 2-3 days after the oocyte retrieval. The other embryos will be cryopreserved for future use. We will use Sidney catheter (Cook Medical Inc.) coupled to a 1 mL syringe to perform the transfer. The catheter will be loaded with embryos in the following sequence: 10 µL of culture medium, a small space of air, 20 µL of the medium containing embryos, another small space of air, and more 10 µL of culture medium. The catheter will be placed through the endocervical canal up to the endometrial cavity, guided by transabdominal ultrasound, where the liquid will be released. We will try to place the point of the catheter 1.0-1.5cm before touching the fundus of the endometrial cavity and release the liquid slowly, in approximately 30 seconds. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women undergoing ART requiring COS, oocyte retrieval and embryo transfer at the fertility clinic of the university Hospital of the Medical School of Ribeirao Preto, University of Sao Paulo, Brazil.
- Age = 18-40 years
- BMI = 18-30 Kg/m²
- Antral follicle count (AFC) ≥ 5
- Semen concentration and progressive motility above the percentile 2.5 of the fertile men (Cooper et al. 2010): sperm concentration > 9X 10⁶/mL, and progressive motility > 28%.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Intrauterine transfer of gametes | Procedure or surgery | Intrauterine transfer of gametes |
| Intrauterine transfer of embryos | Procedure or surgery | intrauterine transfer of embryos |
Primary outcome
Live birth
Time frame: 9 months
2 secondary outcomes
Clinical pregnancy
Time frame: 2 months
Number of oocytes retrieved
Time frame: 1 month
Results and safety
The study was stopped early (reason given: Low pregnancy rates in both groups). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2014.
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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?
A study testing Intrauterine transfer of gametes and Intrauterine transfer of embryos in people with Infertility, run by University of Sao Paulo at 1 site in Brazil.
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 5 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: stopped early, as of the sponsor's last update on 1 Jul 2014. 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 Brazil. 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 was stopped early (reason given: Low pregnancy rates in both groups). 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?
Live birth (time frame: 9 months). 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 Jul 2014.