Pregnant WomenNCT01177904
Early Progesterone Cessation After in Vitro Fertilization
A study testing Cease progsterone at 5 in people with Pregnant Women, run by IVI Madrid at 1 site in Spain.
Trial summary
There seems to be a general consensus on the supplementation of progesterone (P4) for luteal phase support (LPS) to all women after in vitro fertilization (IVF) treatment. However, there is no agreement about the precise duration of LPS. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pregnant Women
- What is being tested?
- Cease progsterone at 5
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2009to Jan 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients who underwent ovarian stimulation using GnRH analogues,
- Fresh embryo transfer,
- LPS by vaginal micronized P4,
- Clinical pregnancy demonstrated by US and
- Informed consent signed.
Who cannot join
- Patients who had bleeding episodes before their first US because they are likely to continue P4 therapy without medical indication.
Trial locations and contacts
1 site in 1 country.
About this study
There seems to be a general consensus on the supplementation of progesterone (P4) for luteal phase support (LPS) to all women after in vitro fertilization (IVF) treatment. However, there is no agreement about the precise duration of LPS.
Read the detailed description
The objective of the study is to investigate the effect of early cessation of progesterone for LPS after IVF treatment on the pregnancy outcome, with special interest in determining the miscarriage rate and episodes of bleeding between the date of the first ultrasound (US) and up to 12 weeks of gestation.
Patients start to receive 200 mg twice a day of P4 on the day after oocyte retrieval.
All patients which show a gestational sac in their uterus in the first US are included in this study and randomized.
Inclusion criteria:
- Patients who underwent ovarian stimulation using GnRH analogues,
- Fresh embryo transfer,
- LPS by vaginal micronized P4,
- Clinical pregnancy demonstrated by US and
- Informed consent signed.
Exclusion criteria:
Patients who had bleeding episodes before their first US because they are likely to continue P4 therapy without medical indication.
- Conditions
- Pregnant Women
- Being tested
- Cease progsterone at 5, control group: progesterone 8
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cease progsterone at 5Other
Cease administration of progsterone at first US at 5 weeks
control group: progesterone 8Other
Control group: progesterone until 8 weeks of pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Progesterone 5 Weeks | Active comparator | The study group stop receiving P4 on the day of their first US at 5 weeks pregnancy Receives: Other: Cease progsterone at 5 |
| Control Group : P4 8 weeks | Other | Progesterone will be given until 8 weeks of pregnancy Receives: Other: control group: progesterone 8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Bleeding Episodes
Number of bleeding episodes up to a year
Measured: Up to year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study startJan 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnant WomenStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Graciela Kohls, IVI Madrid
- Investigators
- Juan A Garcia-Velasco, MD, PhD, Study director, IVI Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177904
- Sponsor's protocol ID
- MAD-GK-01-2009-02
- Status last verified
- Apr 2024
- First submitted
- 5 Aug 2010
- Last updated
- 8 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kohls G, Ruiz F, Martinez M, Hauzman E, de la Fuente G, Pellicer A, Garcia-Velasco JA. Early progesterone cessation after in vitro fertilization/intracytoplasmic sperm injection: a randomized, controlled trial. Fertil Steril. 2012 Oct;98(4):858-62. doi: 10.1016/j.fertnstert.2012.05.046. Epub 2012 Jun 29.
PubMed 22749223
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Progesterone Cessation After in Vitro Fertilization
- ClinicalTrials.gov ID
- NCT01177904
- Acronym / sponsor ID
- MAD-GK-01-2009-02
- Conditions
- Pregnant Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- IVI MadridUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 9 Aug 2010 (estimated)
- Results
- Posted 8 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There seems to be a general consensus on the supplementation of progesterone (P4) for luteal phase support (LPS) to all women after in vitro fertilization (IVF) treatment. However, there is no agreement about the precise duration of LPS.
Detailed description
The objective of the study is to investigate the effect of early cessation of progesterone for LPS after IVF treatment on the pregnancy outcome, with special interest in determining the miscarriage rate and episodes of bleeding between the date of the first ultrasound (US) and up to 12 weeks of gestation.
Patients start to receive 200 mg twice a day of P4 on the day after oocyte retrieval.
All patients which show a gestational sac in their uterus in the first US are included in this study and randomized.
Inclusion criteria:
- Patients who underwent ovarian stimulation using GnRH analogues,
- Fresh embryo transfer,
- LPS by vaginal micronized P4,
- Clinical pregnancy demonstrated by US and
- Informed consent signed.
Exclusion criteria:
Patients who had bleeding episodes before their first US because they are likely to continue P4 therapy without medical indication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progesterone 5 Weeks | Active comparator | Other: Cease progsterone at 5The study group stop receiving P4 on the day of their first US at 5 weeks pregnancy |
| Control Group : P4 8 weeks | Other | Other: control group: progesterone 8Progesterone will be given until 8 weeks of pregnancy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients who underwent ovarian stimulation using GnRH analogues,
- Fresh embryo transfer,
- LPS by vaginal micronized P4,
- Clinical pregnancy demonstrated by US and
- Informed consent signed.
Key exclusion criteria (1 listed)
- Patients who had bleeding episodes before their first US because they are likely to continue P4 therapy without medical indication.
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 |
|---|---|---|
| Cease progsterone at 5Cease administration of progsterone at first US at 5 weeks | Other | Progesterone 5 Weeks |
| control group: progesterone 8Control group: progesterone until 8 weeks of pregnancy | Other | Control Group : P4 8 weeks |
Primary outcome
Number of Bleeding Episodes
Time frame: Up to year
Number of bleeding episodes up to a year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22749223Kohls G, Ruiz F, Martinez M, Hauzman E, de la Fuente G, Pellicer A, Garcia-Velasco JA. Early progesterone cessation after in vitro fertilization/intracytoplasmic sperm injection: a randomized, controlled trial. Fertil Steril. 2012 Oct;98(4):858-62. doi: 10.1016/j.fertnstert.2012.05.046. Epub 2012 Jun 29.
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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.
Juan A Garcia-Velasco, MD, PhD study director
IVI Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cease progsterone at 5 in people with Pregnant Women, run by IVI Madrid 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 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: finished, as of the sponsor's last update on 8 Apr 2024. 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?
Yes. Results are posted in the registry (first posted 8 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Bleeding Episodes (time frame: Up to year). 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 NCT01177904, which also lists 1 linked publication.
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 8 Apr 2024.