InfertilityPhase 3NCT01146418

Frozen-thawed Embryo Transfer (FTET) Cycle Follow-up Protocol (P06031)

A Phase 3 study testing Corifollitropin alfa and recFSH (follitropin beta) in people with Infertility, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this follow-up study is to collect the outcome and safety of FTET cycles after the embryos are cryopreserved in P06029 (NCT01144416). P06029 was a study in which a single injection of corifollitropin alfa (SCH 900962) was compared with daily recombinant follicle stimulating hormone (recFSH) injections… Read more about this study

Who is it for?: Ages 35 to 42 years, women only
Conditions the study is for: Infertility
What is being tested?: Corifollitropin alfa and recFSH (follitropin beta)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 307 participants
Where: No sites listed yet
Study dates: 2 Jun 2010to 29 Apr 2014
Phase: Phase 3
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 35 to 42 years
Women only
No healthy volunteers
Adult

Who may be able to join

Participant must have provided written informed consent for the trial.
Participant must have cryopreserved embryo(s) in trial P06029 (NCT01144416) of which at least one embryo is thawed for use in a subsequent FTET cycle.

Who cannot join

None listed.

About this study

Official title: Follow-up Protocol to Collect the Outcome and Safety of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Study P06029 (Phase 3; Protocol No. P06031)

Conditions: Infertility
Being tested: Corifollitropin alfa, recFSH (follitropin beta)
Keywords: Reproductive Techniques, Assisted, Follicle Stimulating Hormone, Human, Fertilization In Vitro
Medical subject headings: Infertility, Helping Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Corifollitropin alfaBiological
Single injection of 150 μg corifollitropin alfa administered under protocol P06029
recFSH (follitropin beta)Biological
Also called Follistim® AQ Cartridge
Daily recFSH 300 IU administered under protocol P06029.

Study groups in NCT01146418
Study group	Role	What they receive
Corifollitropin alfa 150 μg	Experimental	Participants in Base Study P06029 received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. No medication or investigational product was administered in Follow-Up Study P06031. Receives: Biological: Corifollitropin alfa
recFSH 300 IU	Active comparator	Participants in the reference group in Base Study P06029 received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. No medication or investigational product was administered in Follow-Up Study P06031. Receives: Biological: recFSH (follitropin beta)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate)
The cumulative vital pregnancy rate was defined as the number of participants with at least 1 vital pregnancy in a controlled ovarian stimulation (COS) cycle in Base Study P06029 or a frozen-thawed embryo transfer (FTET) in Follow Up Study P06031, divided by the total number of participants in each Full Analysis Set (FAS) treatment group. A vital pregnancy was defined as an intrauterine pregnancy with fetal heart tones assessed at least 35 days (≥5 weeks) after embryo transfer (ET).
Measured: Assessed at least 35 days after ET in COS cycle in Base Study P06029 or an FTET cycle in Follow-Up Study P06031 (up to 2 years)

Secondary outcomes (1)

Percentage of Participants With ≥1 Live Birth (Cumulative Live-Birth Rate)
The cumulative live-birth rate was defined as the number of participants with at least 1 live birth after ET in a COS cycle in Base Study P06029 or an FTET in Follow-Up Study P06031, divided by the total number of participants in each FAS treatment group.
Measured: From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to time of delivery (up to 2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jun 201029 Apr 2014

First posted17 Jun 2010 (estimated)
Study start2 Jun 2010
Primary completion24 Jul 2013
Study completion29 Apr 2014

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 InfertilityStudies 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 3
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 307 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01146418
Sponsor's protocol ID: P06031
Status last verified: Feb 2022
First submitted: 11 Jun 2010
Last updated: 20 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Boostanfar R, Gates D, Guan Y, Gordon K, McCrary Sisk C, Stegmann BJ. Efficacy and safety of frozen-thawed embryo transfer in women aged 35 to 42 years from the PURSUE randomized clinical trial. Fertil Steril. 2016 Aug;106(2):300-305.e5. doi: 10.1016/j.fertnstert.2016.03.041. Epub 2016 Apr 16.
PubMed 27090863

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)

All Infertility trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Follow-up Protocol to Collect the Outcome and Safety of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Study P06029 (Phase 3; Protocol No. P06031)
ClinicalTrials.gov ID: NCT01146418
Acronym / sponsor ID: P06031
Conditions: Infertility
Keywords: Reproductive Techniques, Assisted, Follicle Stimulating Hormone, Human, Fertilization In Vitro
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 307 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 2 Jun 2010 (actual)
Primary completion: 24 Jul 2013 (actual)
Study completion: 29 Apr 2014 (actual)
First posted: 17 Jun 2010 (estimated)
Results: Posted 3 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Corifollitropin alfa 150 μg	Experimental	Biological: Corifollitropin alfaParticipants in Base Study P06029 received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. No medication or investigational product was administered in Follow-Up Study P06031.
recFSH 300 IU	Active comparator	Biological: recFSH (follitropin beta)Participants in the reference group in Base Study P06029 received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. No medication or investigational product was administered in Follow-Up Study P06031.

Who may qualify

Ages: 35 to 42 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Participant must have provided written informed consent for the trial.
Participant must have cryopreserved embryo(s) in trial P06029 (NCT01144416) of which at least one embryo is thawed for use in a subsequent FTET cycle.

Key exclusion criteria (0 listed)

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 alfaSingle injection of 150 μg corifollitropin alfa administered under protocol P06029	Biological	Corifollitropin alfa 150 μg
recFSH (follitropin beta)Also: Follistim® AQ CartridgeDaily recFSH 300 IU administered under protocol P06029.	Biological	recFSH 300 IU

Primary outcome

Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate)
Time frame: Assessed at least 35 days after ET in COS cycle in Base Study P06029 or an FTET cycle in Follow-Up Study P06031 (up to 2 years)
The cumulative vital pregnancy rate was defined as the number of participants with at least 1 vital pregnancy in a controlled ovarian stimulation (COS) cycle in Base Study P06029 or a frozen-thawed embryo transfer (FTET) in Follow Up Study P06031, divided by the total number of participants in each Full Analysis Set (FAS) treatment group. A vital pregnancy was defined as an intrauterine pregnancy with fetal heart tones assessed at least 35 days (≥5 weeks) after embryo transfer (ET).

1 secondary outcome

Percentage of Participants With ≥1 Live Birth (Cumulative Live-Birth Rate)
Time frame: From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to time of delivery (up to 2 years)

Results and safety

Results posted to the registry on 3 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Corifollitropin Alfa 150 μg Women/Expectant Mothers	694	632
recFSH 300 IU Women/Expectant Mothers	696	647
Corifollitropin Alfa 150 μg Live-Born Infants	0	0
recFSH 300 IU Live-Born Infants	0	0

Primary outcome: Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate)

Time frame: Assessed at least 35 days after ET in COS cycle in Base Study P06029 or an FTET cycle in Follow-Up Study P06031 (up to 2 years). Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Corifollitropin Alfa 150 μg Women/Expectant Mothers n = 694	recFSH 300 IU Women/Expectant Mothers n = 696
Value	31.1 (27.7 to 34.7)	33.0 (29.6 to 36.7)

Corifollitropin Alfa 150 μg Women/Expectant Mothers vs recFSH 300 IU Women/Expectant Mothers: Estimated Difference: -1.8 (95% CI -6.5 to 3.0), Clopper-Pearson method

Population analysed: Full Analysis Set (FAS) population consisted of all randomized participants who received corifollitropin alfa or recFSH in Base Study P06029.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Corifollitropin Alfa 150 μg Participants With ET	4 of 151 (2.6%)	64 of 151 (42.4%)	Not reported
recFSH 300 IU Participants With ET	3 of 147 (2%)	45 of 147 (30.6%)	Not reported
Corifollitropin Alfa 150 μg Expectant Mothers	34 of 52 (65.4%)	26 of 52 (50%)	Not reported
recFSH 300 IU Expectant Mothers	29 of 50 (58%)	19 of 50 (38%)	Not reported
Corifollitropin Alfa 150 μg Follow-up Fetuses/Infants	15 of 61 (24.6%)	18 of 61 (29.5%)	Not reported
recFSH 300 IU Follow-up Fetuses/Infants	17 of 56 (30.4%)	21 of 56 (37.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27090863Boostanfar R, Gates D, Guan Y, Gordon K, McCrary Sisk C, Stegmann BJ. Efficacy and safety of frozen-thawed embryo transfer in women aged 35 to 42 years from the PURSUE randomized clinical trial. Fertil Steril. 2016 Aug;106(2):300-305.e5. doi: 10.1016/j.fertnstert.2016.03.041. Epub 2016 Apr 16.
Individual participant dataSharing planned: No

Related trials for Infertility

RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)

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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Corifollitropin alfa and recFSH (follitropin beta) in people with Infertility, 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 0 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 20 Jun 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Feb 2016). 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 ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate) (time frame: Assessed at least 35 days after ET in COS cycle in Base Study P06029 or an FTET cycle in Follow-Up Study P06031 (up to 2 years)). 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 NCT01146418, 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 20 Jun 2024.