PregnancyGnRH-OvodonNCT00635258
Administration of GnRH Antagonist to Oocyte Donation Recipients
An observational study of Pregnancy and Embryo Implantation, run by Centro Ginecologia y Obstetricia. at 1 site in Spain.
Trial summary
This prospective and randomized study was performed to evaluate whether the replacement of GnRH agonist by a GnRH antagonist in oocyte donation recipients during endometrial preparation has any impact on pregnancy and implantation rates. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Embryo Implantation
- What is being tested?
- triptorelin (Decapeptyl®, Ipsen Pharma, Barcelona, Spain) and GnRH antagonist (Orgalutran®)
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2004to Dec 2007
- 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 18 to 34 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients with an indication for oocyte donation with functioning ovaries.
Who may be able to join
- Age between 18-34 years
- Body mass index between 19-30 kg/m2;
- History of regular menstrual cycles, ranging from 25-35 days
- No relevant systemic disease (all patients were screened for hepatitis B and C, human immunodeficiency viruses I and II, syphylis, and vaginal infection), genetic disease, severe endometriosis or pelvic inflamatory disease
- No more than two previous IVF cycles; and
- No previous IVF cycles with poor response (less than three oocytes in a previous IVF cycle) or severe ovarian hyperstimulation syndrome.
Who cannot join
- Patients without inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Administration of GnRH Antagonist to Oocyte Donation Recipients During Endometrial Preparation.
This prospective and randomized study was performed to evaluate whether the replacement of GnRH agonist by a GnRH antagonist in oocyte donation recipients during endometrial preparation has any impact on pregnancy and implantation rates.
Read the detailed description
This was a prospective and randomized study undertaken between January 2004 and December 2007. One hundred patients with an indication for oocyte donation with functioning ovaries and IVF with or without intracytoplasmatic sperm injection (ICSI) were recruited for the study. After assignment to IVF or IVF/ICSI randomization was performed to 1 of the 2 treatment groups (GnRH agonist or GnRH antagonist during endometrial preparation in oocyte donation recipients) using a computed-generated randomization schedule assigned via numbered sealed envelopes.
In our program, we used excess oocytes from IVF that were voluntarily donated by patients after informed consent.
The indications for oocyte donation were reduced ovarian reserve (59%), recurrent IVF failures (21%), premature ovarian failure (16%), and genetic anomaly (4%).
This study was performed according to the declaration of Helsinki and the European Community note on Good Clinical Practice for trials on medical products in the European Community (CPMP Working Party on Efficacy of Medical Products, 1990). Furthermore, the local ethics committee approved the study protocol, and written informed consent was obtained from all patients.
- Conditions
- Pregnancy, Embryo Implantation
- Being tested
- triptorelin (Decapeptyl®, Ipsen Pharma, Barcelona, Spain), GnRH antagonist (Orgalutran®)
- Keywords
- GnRH antagonist, oocyte donation, pregnancy, implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triptorelin (Decapeptyl®, Ipsen Pharma, Barcelona, Spain)Drug
Also called GnRH agonist
0.1 mg/day triptorelin s.c (Decapeptyl®, Ipsen Pharma, Barcelona, Spain) was started on day 21-24 of the preceding cycle for at least 14 days to produce an agonadal state.
GnRH antagonist (Orgalutran®)Drug
Also called GnRH antagonist
GnRH antagonist (Orgalutran®; 0,25 mg/d, sc.) commencing on day 1 of the menstrual cycle and maintained until the day of donor's hCG administration.
| Study group | Role | What they receive |
|---|---|---|
| GnRH-ant | Patients were treated with a GnRH antagonist (Orgalutran®; 0,25 mg/d, sc.) commencing on day 1 of the menstrual cycle and maintained until the day of donor's hCG administration. Receives: Drug: GnRH antagonist (Orgalutran®) | |
| GnRH-a | GnRH long protocol using 0.1 mg/day triptorelin s.c (Decapeptyl®, Ipsen Pharma, Barcelona, Spain) was started on day 21-24 of the preceding cycle for at least 14 days to produce an agonadal state. Furthermore, the triptorelin administration was maintained until the day of donor's hCG administration. Receives: Drug: triptorelin (Decapeptyl®, Ipsen Pharma, Barcelona, Spain) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy and implantation rates
Measured: "at 7 weeks"
Secondary outcomes (1)
age of the recipients, body mass index, days undergoing oestrogen therapy
Measured: "at 1 mounth"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startJan 2004
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Ginecologia y Obstetricia.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Valencia
- Investigators
- Raga Francisco, M.D., Ph.D., Principal investigator, Centro Ginecologia y Obstetricia.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635258
- Sponsor's protocol ID
- GnRH-ant.Ovodon
- Acronym
- GnRH-Ovodon
- Status last verified
- Mar 2008
- First submitted
- 26 Feb 2008
- Last updated
- 13 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Casan EM, Raga F, Bonilla-Musoles F, Polan ML. Human oviductal gonadotropin-releasing hormone: possible implications in fertilization, early embryonic development, and implantation. J Clin Endocrinol Metab. 2000 Apr;85(4):1377-81. doi: 10.1210/jcem.85.4.6503.
PubMed 10770169Raga F, Casan EM, Kruessel J, Wen Y, Bonilla-Musoles F, Polan ML. The role of gonadotropin-releasing hormone in murine preimplantation embryonic development. Endocrinology. 1999 Aug;140(8):3705-12. doi: 10.1210/endo.140.8.6899.
PubMed 10433230Casan EM, Raga F, Polan ML. GnRH mRNA and protein expression in human preimplantation embryos. Mol Hum Reprod. 1999 Mar;5(3):234-9. doi: 10.1093/molehr/5.3.234.
PubMed 10333357Raga F, Casan EM, Wen Y, Huang HY, Bonilla-Musoles F, Polan ML. Independent regulation of matrix metalloproteinase-9, tissue inhibitor of metalloproteinase-1 (TIMP-1), and TIMP-3 in human endometrial stromal cells by gonadotropin-releasing hormone: implications in early human implantation. J Clin Endocrinol Metab. 1999 Feb;84(2):636-42. doi: 10.1210/jcem.84.2.5464.
PubMed 10022430Raga F, Casan EM, Kruessel JS, Wen Y, Huang HY, Nezhat C, Polan ML. Quantitative gonadotropin-releasing hormone gene expression and immunohistochemical localization in human endometrium throughout the menstrual cycle. Biol Reprod. 1998 Sep;59(3):661-9. doi: 10.1095/biolreprod59.3.661.
PubMed 9716567
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of GnRH Antagonist to Oocyte Donation Recipients During Endometrial Preparation.
- ClinicalTrials.gov ID
- NCT00635258
- Acronym / sponsor ID
- GnRH-Ovodon / GnRH-ant.Ovodon
- Conditions
- Pregnancy, Embryo Implantation
- Keywords
- GnRH antagonist, oocyte donation, pregnancy, implantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centro Ginecologia y Obstetricia.University, hospital or other
- Collaborators
- University of Valencia
- Study start
- Jan 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 13 Mar 2008 (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.
This prospective and randomized study was performed to evaluate whether the replacement of GnRH agonist by a GnRH antagonist in oocyte donation recipients during endometrial preparation has any impact on pregnancy and implantation rates.
Detailed description
This was a prospective and randomized study undertaken between January 2004 and December 2007. One hundred patients with an indication for oocyte donation with functioning ovaries and IVF with or without intracytoplasmatic sperm injection (ICSI) were recruited for the study. After assignment to IVF or IVF/ICSI randomization was performed to 1 of the 2 treatment groups (GnRH agonist or GnRH antagonist during endometrial preparation in oocyte donation recipients) using a computed-generated randomization schedule assigned via numbered sealed envelopes.
In our program, we used excess oocytes from IVF that were voluntarily donated by patients after informed consent.
The indications for oocyte donation were reduced ovarian reserve (59%), recurrent IVF failures (21%), premature ovarian failure (16%), and genetic anomaly (4%).
This study was performed according to the declaration of Helsinki and the European Community note on Good Clinical Practice for trials on medical products in the European Community (CPMP Working Party on Efficacy of Medical Products, 1990). Furthermore, the local ethics committee approved the study protocol, and written informed consent was obtained from all patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GnRH-ant | – | Drug: GnRH antagonist (Orgalutran®)Patients were treated with a GnRH antagonist (Orgalutran®; 0,25 mg/d, sc.) commencing on day 1 of the menstrual cycle and maintained until the day of donor's hCG administration. |
| GnRH-a | – | Drug: triptorelin (Decapeptyl®, Ipsen Pharma, Barcelona, Spain)GnRH long protocol using 0.1 mg/day triptorelin s.c (Decapeptyl®, Ipsen Pharma, Barcelona, Spain) was started on day 21-24 of the preceding cycle for at least 14 days to produce an agonadal state. Furthermore, the triptorelin administration was maintained until the day of donor's hCG administration. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with an indication for oocyte donation with functioning ovaries.
Key inclusion criteria (6 listed)
- Age between 18-34 years
- Body mass index between 19-30 kg/m2;
- History of regular menstrual cycles, ranging from 25-35 days
- No relevant systemic disease (all patients were screened for hepatitis B and C, human immunodeficiency viruses I and II, syphylis, and vaginal infection), genetic disease, severe endometriosis or pelvic inflamatory disease
- No more than two previous IVF cycles; and
Key exclusion criteria (1 listed)
- Patients without inclusion criteria.
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 |
|---|---|---|
| triptorelin (Decapeptyl®, Ipsen Pharma, Barcelona, Spain)Also: GnRH agonist0.1 mg/day triptorelin s.c (Decapeptyl®, Ipsen Pharma, Barcelona, Spain) was started on day 21-24 of the preceding cycle for at least 14 days to produce an agonadal state. | Drug | GnRH-a |
| GnRH antagonist (Orgalutran®)Also: GnRH antagonistGnRH antagonist (Orgalutran®; 0,25 mg/d, sc.) commencing on day 1 of the menstrual cycle and maintained until the day of donor's hCG administration. | Drug | GnRH-ant |
Primary outcome
pregnancy and implantation rates
Time frame: "at 7 weeks"
1 secondary outcome
age of the recipients, body mass index, days undergoing oestrogen therapy
Time frame: "at 1 mounth"
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 13 Mar 2008.
- Background: PubMed 10770169Casan EM, Raga F, Bonilla-Musoles F, Polan ML. Human oviductal gonadotropin-releasing hormone: possible implications in fertilization, early embryonic development, and implantation. J Clin Endocrinol Metab. 2000 Apr;85(4):1377-81. doi: 10.1210/jcem.85.4.6503.
- Background: PubMed 10433230Raga F, Casan EM, Kruessel J, Wen Y, Bonilla-Musoles F, Polan ML. The role of gonadotropin-releasing hormone in murine preimplantation embryonic development. Endocrinology. 1999 Aug;140(8):3705-12. doi: 10.1210/endo.140.8.6899.
- Background: PubMed 10333357Casan EM, Raga F, Polan ML. GnRH mRNA and protein expression in human preimplantation embryos. Mol Hum Reprod. 1999 Mar;5(3):234-9. doi: 10.1093/molehr/5.3.234.
- Background: PubMed 10022430Raga F, Casan EM, Wen Y, Huang HY, Bonilla-Musoles F, Polan ML. Independent regulation of matrix metalloproteinase-9, tissue inhibitor of metalloproteinase-1 (TIMP-1), and TIMP-3 in human endometrial stromal cells by gonadotropin-releasing hormone: implications in early human implantation. J Clin Endocrinol Metab. 1999 Feb;84(2):636-42. doi: 10.1210/jcem.84.2.5464.
- Background: PubMed 9716567Raga F, Casan EM, Kruessel JS, Wen Y, Huang HY, Nezhat C, Polan ML. Quantitative gonadotropin-releasing hormone gene expression and immunohistochemical localization in human endometrium throughout the menstrual cycle. Biol Reprod. 1998 Sep;59(3):661-9. doi: 10.1095/biolreprod59.3.661.
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
Raga Francisco, M.D., Ph.D. principal investigator
Centro Ginecologia y Obstetricia.
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 and Embryo Implantation, run by Centro Ginecologia y Obstetricia. at 1 site in Spain.
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 6 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 13 Mar 2008. 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 Spain. 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?
pregnancy and implantation rates (time frame: "at 7 weeks"). 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 NCT00635258, which also lists 5 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 13 Mar 2008.