In Vitro FertilizationNCT00702273
Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716)
An observational study of In Vitro Fertilization, run by Organon and Co.
Trial summary
To collect the outcome of frozen-thawed embryo transfer cycles after the embryos are cryopreserved up to at least 1 year in Trial P05787 (NCT00696800), 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?
- 150 µg Corifollitropin Alfa, 200 IU RecFSH/Follitropin beta (Days 1 to 7) and 200 IU RecFSH/Follitropin beta (Days 8 to hCG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 344 participants
- Where
- No sites listed yet
- Study dates
- 19 Apr 2006to 31 May 2009
- 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 Trial P05787 (NCT00696800).
Who may be able to join
- Participants from whom embryos have been cryopreserved in Base Trial P05787 (NCT00696800), of which at least one embryo is thawed for use in a subsequent FTET cycle;
- Able and willing to give 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 38819
To collect the outcome of frozen-thawed embryo transfer cycles after the embryos are cryopreserved up to at least 1 year in Trial P05787 (NCT00696800), 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 frozen-thawed embryo transfer cycles, performed after the embryos are cryopreserved up to at least 1 year in Trial P05787 (NCT00696800), to enable estimation of the cumulative pregnancy rate for each treatment group.
- Conditions
- In Vitro Fertilization
- Being tested
- 150 µg Corifollitropin Alfa, 200 IU RecFSH/Follitropin beta (Days 1 to 7), Placebo for Corifollitropin Alfa, Placebo for RecFSH/Follitropin beta, 200 IU RecFSH/Follitropin beta (Days 8 to hCG)
- 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.
150 µg Corifollitropin AlfaDrug
On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg (0.5 mL) Corifollitropin Alfa was administered in the abdominal wall.
200 IU RecFSH/Follitropin beta (Days 1 to 7)Biological
Daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
Placebo for Corifollitropin AlfaDrug
Pre-filled syringe containing an identical solution when compared to Corifollitropin Alfa. On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection was administered in the abdominal wall.
Placebo for RecFSH/Follitropin betaDrug
Identical ready-for-use solution, but without the active ingredient, supplied in cartridges for SC injection with the Follistim Pen. Daily SC injections were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
200 IU RecFSH/Follitropin beta (Days 8 to hCG)Biological
From Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.
GanirelixDrug
On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG
hCGBiological
When 3 follicles >= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP
ProgesteroneBiological
On the day of OPU, luteal phase support was started by administering micronized progesterone of at least 600 mg/day vaginally, or at least 50 mg/day intramuscular (IM), which continued for at least 6 weeks, or up to menses.
| Study group | Role | What they receive |
|---|---|---|
| 150 µg Corifollitropin Alfa | Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa (Org 36286) on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recombinant Follicle Stimulating Hormone (recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles. Receives: Drug: 150 µg Corifollitropin Alfa; Drug: Placebo for RecFSH/Follitropin beta; Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG); Drug: Ganirelix; Biological: hCG; Biological: Progesterone | |
| 200 IU RecFSH | Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles. Receives: Biological: 200 IU RecFSH/Follitropin beta (Days 1 to 7); Drug: Placebo for Corifollitropin Alfa; Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG); Drug: Ganirelix; Biological: hCG; Biological: Progesterone |
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)
An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed by live birth.The cumulative ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base Trial P05787 (NCT00696800), or after one or more FTET cycles in follow-up Trial P05716 following cryopreservation, divided by the total number of participants that started treatment in base Trial P05787 (NCT00696800). Participants who did not have cryopreserved embryos, or embryo transfers in the FTET cycle(s), were considered 'not pregnant'.
Measured: Up to 1 year after embryo transfer in base trial P05787 (NCT00696800), and FTET cycles in follow up trial
Secondary outcomes (6)
Percentage of Participants in Follow up Trial With a Miscarriage Per Clinical Pregnancy
Miscarriages were calculated per clinical pregnancy, meaning the presence of at least one gestational sac or confirmed by live birth.
Measured: After one or more FTET cycles, up to day of miscarriage (up to 1 year)
Percentage of Participants in Follow up Trial With a Miscarriage Per Vital Pregnancy
Miscarriages were calculated per vital pregnancy, meaning the presence of at least one fetus with heart activity.
Measured: After one or more FTET cycles, up to day of miscarriage (up to 1 year)
Percentage of Participants in Follow up Trial With an Ectopic 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 Trial 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 Trial 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 in Follow up Trial 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 start19 Apr 2006
- Primary completion19 May 2009
- Study completion31 May 2009
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 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
- 344 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
- NCT00702273
- Sponsor's protocol ID
- P05716
- Other IDs
- 2004-004773-28, 38831, MK-8962-009, 2004
- Status last verified
- Feb 2022
- First submitted
- 18 Jun 2008
- Last updated
- 5 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Boostanfar R, Mannaerts B, Pang S, Fernandez-Sanchez M, Witjes H, Devroey P; Engage Investigators. A comparison of live birth rates and cumulative ongoing pregnancy rates between Europe and North America after ovarian stimulation with corifollitropin alfa or recombinant follicle-stimulating hormone. Fertil Steril. 2012 Jun;97(6):1351-8. doi: 10.1016/j.fertnstert.2012.02.038. Epub 2012 Mar 28.
PubMed 22459628
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. 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 38819
- ClinicalTrials.gov ID
- NCT00702273
- Acronym / sponsor ID
- P05716
- Conditions
- In Vitro Fertilization
- Keywords
- In-vitro fertilization, Controlled Ovarian Stimulation, Cumulative pregnancy data, Follow-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2006 (actual)
- Primary completion
- 19 May 2009 (actual)
- Study completion
- 31 May 2009 (actual)
- First posted
- 20 Jun 2008 (estimated)
- Results
- Posted 20 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To collect the outcome of frozen-thawed embryo transfer cycles after the embryos are cryopreserved up to at least 1 year in Trial P05787 (NCT00696800), 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 frozen-thawed embryo transfer cycles, performed after the embryos are cryopreserved up to at least 1 year in Trial P05787 (NCT00696800), 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 |
|---|---|---|
| 150 µg Corifollitropin Alfa | – | Drug: 150 µg Corifollitropin Alfa, Drug: Placebo for RecFSH/Follitropin beta, Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG), Drug: Ganirelix, Biological: hCG, Biological: ProgesteroneParticipants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa (Org 36286) on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recombinant Follicle Stimulating Hormone (recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles. |
| 200 IU RecFSH | – | Biological: 200 IU RecFSH/Follitropin beta (Days 1 to 7), Drug: Placebo for Corifollitropin Alfa, Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG), Drug: Ganirelix, Biological: hCG, Biological: ProgesteroneParticipants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles. |
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 Trial P05787 (NCT00696800).
Key inclusion criteria (2 listed)
- Participants from whom embryos have been cryopreserved in Base Trial P05787 (NCT00696800), of which at least one embryo is thawed for use in a subsequent FTET cycle;
- Able and willing to give 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 |
|---|---|---|
| 150 µg Corifollitropin AlfaOn the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg (0.5 mL) Corifollitropin Alfa was administered in the abdominal wall. | Drug | 150 µg Corifollitropin Alfa |
| 200 IU RecFSH/Follitropin beta (Days 1 to 7)Daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7. | Biological | 200 IU RecFSH |
| Placebo for Corifollitropin AlfaPre-filled syringe containing an identical solution when compared to Corifollitropin Alfa. On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection was administered in the abdominal wall. | Drug | 200 IU RecFSH |
| Placebo for RecFSH/Follitropin betaIdentical ready-for-use solution, but without the active ingredient, supplied in cartridges for SC injection with the Follistim Pen. Daily SC injections were started on Stimulation Day 1 and continued up to and including Stimulation Day 7. | Drug | 150 µg Corifollitropin Alfa |
| 200 IU RecFSH/Follitropin beta (Days 8 to hCG)From Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG. | Biological | 150 µg Corifollitropin Alfa, 200 IU RecFSH |
| GanirelixOn Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG | Drug | 150 µg Corifollitropin Alfa, 200 IU RecFSH |
| hCGWhen 3 follicles >= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP | Biological | 150 µg Corifollitropin Alfa, 200 IU RecFSH |
| ProgesteroneOn the day of OPU, luteal phase support was started by administering micronized progesterone of at least 600 mg/day vaginally, or at least 50 mg/day intramuscular (IM), which continued for at least 6 weeks, or up to menses. | Biological | 150 µg Corifollitropin Alfa, 200 IU RecFSH |
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 P05787 (NCT00696800), and FTET cycles in follow up trial
An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed by live birth.The cumulative ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base Trial P05787 (NCT00696800), or after one or more FTET cycles in follow-up Trial P05716 following cryopreservation, divided by the total number of participants that started treatment in base Trial P05787 (NCT00696800). Participants who did not have cryopreserved embryos, or embryo transfers in the FTET cycle(s), were considered 'not pregnant'.
6 secondary outcomes
Percentage of Participants in Follow up Trial With a Miscarriage Per Clinical Pregnancy
Time frame: After one or more FTET cycles, up to day of miscarriage (up to 1 year)
Percentage of Participants in Follow up Trial With a Miscarriage Per Vital Pregnancy
Time frame: After one or more FTET cycles, up to day of miscarriage (up to 1 year)
Percentage of Participants in Follow up Trial With an Ectopic 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 Trial 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 Trial 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 in Follow up Trial 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 5 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22459628Boostanfar R, Mannaerts B, Pang S, Fernandez-Sanchez M, Witjes H, Devroey P; Engage Investigators. A comparison of live birth rates and cumulative ongoing pregnancy rates between Europe and North America after ovarian stimulation with corifollitropin alfa or recombinant follicle-stimulating hormone. Fertil Steril. 2012 Jun;97(6):1351-8. doi: 10.1016/j.fertnstert.2012.02.038. Epub 2012 Mar 28.
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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.
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 5 Sep 2024. 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 20 Nov 2014). 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 P05787 (NCT00696800), and FTET cycles in follow up trial). 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 NCT00702273, 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 5 Sep 2024.