Follow-up Protocol on the Outcome of Frozen-thawed Embryo Transfer Cycles From Clinical Trial P05690 (P05711)

Follow-up Protocol to Collect the Outcome of Frozen-thawed Embryo Transfer Cycles After Cryopreservation of Embryos in Clinical Trial 107012

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00702546

Enrollment

102

Registered

2008-06-20

Start date

2006-12-31

Completion date

2008-12-31

Last updated

2022-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

In Vitro Fertilization

Keywords

In-vitro fertilization, Controlled Ovarian Stimulation, Cumulative pregnancy data, Follow-up

Brief 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.

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.

Interventions

DRUGcorifollitropin alfa

Single injection of 100 μg corifollitropin alfa administered under protocol P05690

BIOLOGICALrecFSH (follitropin alfa)

Daily recFSH administered under protocol P05690

DRUGgonadatropin releasing hormone (GnRH) antagonist ganirelix

GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690

DRUGhuman chorion gonadatropin (hCG)

hCG 5,000 IU or 10,000 IU administered SC under protocol P05690

BIOLOGICALprogesterone

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.

DRUGplacebo-recFSH (follitropin alfa)

Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690

DRUGplacebo-corifollitropin alfa

Single SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690

BIOLOGICALopen-label recFSH

Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P0590

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 36 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)	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.

Secondary

Measure	Time frame	Description
Percentage of Participants in Follow up Study With a Miscarriage Per Vital Pregnancy	After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)	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.
Percentage of Participants in Follow up Study With an Ecotopic Pregnancy	After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)	An ectopic pregnancy is where the embryo implants outside the uterus. Ectopic pregnancies were calculated per total number of participants started in FTET.
Percentage of Participants in Follow up Study With a Miscarriage Per Clinical Pregnancy	After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)	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.
Percentage of Participants in Follow up Study With a Vital Pregnancy	After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)	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.
Percentage of Participants With an Ongoing Pregnancy	After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)	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.
Percentage of Participants in Follow up Study With a Clinical Pregnancy	After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)	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.

Participant flow

Pre-assignment details

Period one consists of participants from the base study P05690 (NCT00702845) randomized to treatment groups corifollitropin alfa (Org 36286) or recombinant Follicle Stimulating Hormone (recFSH). Period two consists of eligible participants (N = 102) from the base study who enrolled in the follow up study P05711.

Participants by arm

Arm	Count
Corifollitropin Alfa 100 μg Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.	77
recFSH 150 IU Participants in the reference group in base study P05690 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 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 (10,000 or 5,000 IU/USP). 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. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.	25
Total	102

Baseline characteristics

Characteristic	Corifollitropin Alfa 100 μg	recFSH 150 IU	Total
Age, Continuous	31.2 Years STANDARD_DEVIATION 3	31.2 Years STANDARD_DEVIATION 2.8	31.2 Years STANDARD_DEVIATION 2.9
Sex: Female, Male Female	77 Participants	25 Participants	102 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	1 / 77	0 / 25

Outcome results

Primary

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.

Time frame: Up to 1 year after embryo transfer in base trial P05690 (NCT00702845), and FTET cycles in follow up study P05711

Population: Intent-to-Treat (ITT) group from base study P05690 (NCT00702845), which consisted of randomized participants who were treated with corifollitropin alfa or recFSH.

Arm	Measure	Value (NUMBER)
Corifollitropin Alfa 100 μg	Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)	32.1 Percentage of participants
recFSH 150 IU	Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)	41.4 Percentage of participants

Comparison: Treatment groups were compared with a generalized linear model for the cumulative ongoing pregnancy rate including covariates treatment group, age class (\< 32 yrs vs. ≥ 32 yrs), planned IVF treatment (IVF vs. ICSI) and region (Europe vs. Asia).95% CI: [-19.5, 0.7]

Secondary

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.