In Vitro FertilizationNCT00702546
Follow-up Protocol on the Outcome of Frozen-thawed Embryo Transfer Cycles From Clinical Trial P05690 (P05711)
An observational study of In Vitro Fertilization, run by Organon and Co.
Trial summary
Clinical trial objective is to collect the outcome of Frozen-Thawed Embryo Transfer (FTET) cycles performed after the embryos are cryopreserved in the base study P05690 in order to estimate the cumulative pregnancy rate for each treatment group. Read more about this study
- Who is it for?
- Ages 18 to 36 years, women only
- Conditions the study is for
- In Vitro Fertilization
- What is being tested?
- corifollitropin alfa, recFSH (follitropin alfa) and gonadatropin releasing hormone (GnRH) antagonist ganirelix
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Dec 2008
- Phase
- Observational
- 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 36 years
- Women only
- No healthy volunteers
- Adult
Study population: Women from whom embryos have been cryopreserved in base study P05690
Who may be able to join
- Participants from whom embryos have been cryopreserved in base study P05690, of which at least one embryo is thawed for use in a subsequent FTET cycle;
- Able and willing to give written informed consent.
Who cannot join
- None
About this study
Official title: Follow-up Protocol to Collect the Outcome of Frozen-thawed Embryo Transfer Cycles After Cryopreservation of Embryos in Clinical Trial 107012
Clinical trial objective is to collect the outcome of Frozen-Thawed Embryo Transfer (FTET) cycles performed after the embryos are cryopreserved in the base study P05690 in order to estimate the cumulative pregnancy rate for each treatment group.
Read the detailed description
This is a follow-up protocol to collect the outcome of FTET cycles, performed after the embryos are cryopreserved in base study P05690 (NCT00702845), to enable estimation of the cumulative pregnancy rate for each treatment group.
- Conditions
- In Vitro Fertilization
- Being tested
- corifollitropin alfa, recFSH (follitropin alfa), gonadatropin releasing hormone (GnRH) antagonist ganirelix, human chorion gonadatropin (hCG), progesterone
- Keywords
- In-vitro fertilization, Controlled Ovarian Stimulation, Cumulative pregnancy data, Follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corifollitropin alfaDrug
Also called Org 36286
Single injection of 100 μg corifollitropin alfa administered under protocol P05690
recFSH (follitropin alfa)Biological
Also called Puregon®/Follistim®
Daily recFSH administered under protocol P05690
gonadatropin releasing hormone (GnRH) antagonist ganirelixDrug
GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690
human chorion gonadatropin (hCG)Drug
hCG 5,000 IU or 10,000 IU administered SC under protocol P05690
progesteroneBiological
Under protocol P05690, progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM.
placebo-recFSH (follitropin alfa)Drug
Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690
placebo-corifollitropin alfaDrug
Single SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690
open-label recFSHBiological
Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P0590
| Study group | Role | What they receive |
|---|---|---|
| Corifollitropin alfa 100 μg | In follow-up study, no medication or investigational product was administered. But in base study P05690 (NCT00702845), participants received single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants in base study P05690 also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses. Receives: Drug: corifollitropin alfa; Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix; Drug: human chorion gonadatropin (hCG); Biological: progesterone; Drug: placebo-recFSH (follitropin alfa); Biological: open-label recFSH | |
| recFSH 150 IU | In this follow-up study, no medication or investigational product was administered. However, in base study P05690 (NCT00702845), participants in the reference group received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses. Receives: Biological: recFSH (follitropin alfa); Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix; Drug: human chorion gonadatropin (hCG); Biological: progesterone; Drug: placebo-corifollitropin alfa; Biological: open-label recFSH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)
Cumulative ongoing pregnancy rate was defined as 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base study P05690 (NCT00702845) or after one or more FTET cycles in follow up study P05711 following cryopreservation, divided by the total number of subjects that started treatment in base study P05690.
Measured: Up to 1 year after embryo transfer in base trial P05690 (NCT00702845), and FTET cycles in follow up study P05711
Secondary outcomes (6)
Percentage of Participants in Follow up Study With a Miscarriage Per Clinical Pregnancy
Miscarriages were calculated per clinical pregnancy, defined as the presence of at least one gestational sac as assessed by USS or Doppler, or confirmed by live birth.
Measured: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
Percentage of Participants in Follow up Study With a Miscarriage Per Vital Pregnancy
Miscarriages were calculated per vital pregnancy, defined as the presence of at least one fetus with heart activity as assessed by USS or Doppler, or confirmed by live birth.
Measured: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
Percentage of Participants in Follow up Study With an Ecotopic Pregnancy
An ectopic pregnancy is where the embryo implants outside the uterus. Ectopic pregnancies were calculated per total number of participants started in FTET.
Measured: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
Percentage of Participants in Follow up Study With a Clinical Pregnancy
A clinical pregnancy is the presence of at least gestational sac or confirmed by live birth. Clinical pregnancies were calculated per attempt, meaning if any stage of in vitro fertilization (IVF) treatment was not achieved, zero values were imputed.
Measured: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
Percentage of Participants in Follow up Study With a Vital Pregnancy
A vital pregnancy is the presence of at least one fetus with heart activity. Vital pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.
Measured: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
Percentage of Participants With an Ongoing Pregnancy
An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed at live birth. Ongoing pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.
Measured: After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study startDec 2006
- Primary completionDec 2008
- Study completionDec 2008
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.
- Other trials for In Vitro FertilizationStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702546
- Sponsor's protocol ID
- P05711
- Other IDs
- 2006-003813-42, 107015, MK-8962-004
- Status last verified
- Feb 2022
- First submitted
- 18 Jun 2008
- Last updated
- 3 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Protocol to Collect the Outcome of Frozen-thawed Embryo Transfer Cycles After Cryopreservation of Embryos in Clinical Trial 107012
- ClinicalTrials.gov ID
- NCT00702546
- Acronym / sponsor ID
- P05711
- Conditions
- In Vitro Fertilization
- Keywords
- In-vitro fertilization, Controlled Ovarian Stimulation, Cumulative pregnancy data, Follow-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 Jun 2008 (estimated)
- Results
- Posted 5 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical trial objective is to collect the outcome of Frozen-Thawed Embryo Transfer (FTET) cycles performed after the embryos are cryopreserved in the base study P05690 in order to estimate the cumulative pregnancy rate for each treatment group.
Detailed description
This is a follow-up protocol to collect the outcome of FTET cycles, performed after the embryos are cryopreserved in base study P05690 (NCT00702845), to enable estimation of the cumulative pregnancy rate for each treatment group.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corifollitropin alfa 100 μg | – | Drug: corifollitropin alfa, Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix, Drug: human chorion gonadatropin (hCG), Biological: progesterone, Drug: placebo-recFSH (follitropin alfa), Biological: open-label recFSHIn follow-up study, no medication or investigational product was administered. But in base study P05690 (NCT00702845), participants received single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants in base study P05690 also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses. |
| recFSH 150 IU | – | Biological: recFSH (follitropin alfa), Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix, Drug: human chorion gonadatropin (hCG), Biological: progesterone, Drug: placebo-corifollitropin alfa, Biological: open-label recFSHIn this follow-up study, no medication or investigational product was administered. However, in base study P05690 (NCT00702845), participants in the reference group received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses. |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women from whom embryos have been cryopreserved in base study P05690
Key inclusion criteria (2 listed)
- Participants from whom embryos have been cryopreserved in base study P05690, of which at least one embryo is thawed for use in a subsequent FTET cycle;
- Able and willing to give written informed consent.
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 |
|---|---|---|
| corifollitropin alfaAlso: Org 36286Single injection of 100 μg corifollitropin alfa administered under protocol P05690 | Drug | Corifollitropin alfa 100 μg |
| recFSH (follitropin alfa)Also: Puregon®/Follistim®Daily recFSH administered under protocol P05690 | Biological | recFSH 150 IU |
| gonadatropin releasing hormone (GnRH) antagonist ganirelixGnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690 | Drug | Corifollitropin alfa 100 μg, recFSH 150 IU |
| human chorion gonadatropin (hCG)hCG 5,000 IU or 10,000 IU administered SC under protocol P05690 | Drug | Corifollitropin alfa 100 μg, recFSH 150 IU |
| progesteroneUnder protocol P05690, progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM. | Biological | Corifollitropin alfa 100 μg, recFSH 150 IU |
| placebo-recFSH (follitropin alfa)Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690 | Drug | Corifollitropin alfa 100 μg |
| placebo-corifollitropin alfaSingle SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690 | Drug | recFSH 150 IU |
| open-label recFSHOpen-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P0590 | Biological | Corifollitropin alfa 100 μg, recFSH 150 IU |
Primary outcome
Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)
Time frame: Up to 1 year after embryo transfer in base trial P05690 (NCT00702845), and FTET cycles in follow up study P05711
Cumulative ongoing pregnancy rate was defined as 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base study P05690 (NCT00702845) or after one or more FTET cycles in follow up study P05711 following cryopreservation, divided by the total number of subjects that started treatment in base study P05690.
6 secondary outcomes
Percentage of Participants in Follow up Study With a Miscarriage Per Clinical Pregnancy
Time frame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
Percentage of Participants in Follow up Study With a Miscarriage Per Vital Pregnancy
Time frame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
Percentage of Participants in Follow up Study With an Ecotopic Pregnancy
Time frame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
Percentage of Participants in Follow up Study With a Clinical Pregnancy
Time frame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
Percentage of Participants in Follow up Study With a Vital Pregnancy
Time frame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
Percentage of Participants With an Ongoing Pregnancy
Time frame: After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for In Vitro Fertilization
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
RecruitingPhase 2
Ubiquinone vs. Ubiquinol Supplementation
IVF
Recruiting
Trigger Timing in Ovarian Stimulations
IVF Outcome
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
RecruitingPhase 4
Study of G-CSF for DOR in Patients Undergoing IVF
Diminished Ovarian Reserve, IVF
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.
Questions about this trial
What is this clinical trial studying?
An observational study of In Vitro Fertilization, run by Organon and Co.
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 2 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 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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 5 May 2015). 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?
Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate) (time frame: Up to 1 year after embryo transfer in base trial P05690 (NCT00702845), and FTET cycles in follow up study P05711). 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 3 Feb 2022.