Neonates, Pregnancy
Conditions
Keywords
Neonatal outcome, Congenital malformations, In-Vitro fertilization, Controlled ovarian stimulation, Follow-up
Brief summary
The objective of this trial is to evaluate whether corifollitropin alfa (MK-8962, Org 36286) treatment for the induction of multifollicular growth in women undergoing Controlled Ovarian Stimulation (COS) prior to in vitro fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) is safe for pregnant participants and their offspring.
Detailed description
This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcomes of all women who were treated with corifollitropin alfa and became pregnant during the base Trial 38833. For this follow-up trial (38834), no investigational products will be administered and no study specific assessments are required, but information will be obtained as per standard clinical practice.
Interventions
DRUGCorifollitropin alpha (MK-8962, Org 36286) 100 ug
Subcutaneous administration of corifollitropin alpha at a dose of 100 ug
DRUGCorifollitropin alpha (MK-8962, Org 36286) 150 ug
Subcutaneous administration of corifollitropin alpha at a dose of 150 ug
DRUGTriptorelin
Daily SC injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase).
From stimulation Day 8 onwards, treatment was continued with daily SC of recFSH injections (maximally 200 IU) up to and including the day of administration of hCG.
BIOLOGICALHuman chorionic gonadotprophin (hCG).
HCG was administered as a single subcutaneous injection of 5,000 to 10,000 international units.
Sponsors
Organon and Co
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* Participants who received one dose of corifollitropin alfa in Trial 38833; * Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in Trial 38833; * Able and willing to give written informed consent.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Expectant Mothers Experiencing Adverse Events (AEs) | Up to 1 Year | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug. |
| Number of Expectant Mothers Experiencing Serious AEs (SAEs) | Up to 1 Year | An AE or suspected adverse reaction is considered serious if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. |
| Number of Infants Experiencing AEs | Up to 1 Year | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug. |
| Number of Infants Experiencing SAEs | Up to 1 Year | An AE or suspected adverse reaction is considered serious if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. |
| Take-Home Baby Rate | Birth of a one or more live babies (Up to 1 year) | The take-home baby rate was calculated as the number of participants with a least one live born infant in the follow-up study (P05783, 38834, NCT00702520) relative to the number of participants treated with Corifollitropin alpha in the base study (P05788, 38833, NCT00702351). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Expectant Mothers Administered Corifollitropin Alpha 100 ug In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing \<= 60 kg. No study medications were administered in the follow-up P05783 study. | 7 |
| Expectant Mothers Administered Corifollitropin Alpha 150 ug In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing \>= 50 kg. No study medications were administered in the follow-up P05783 study. | 8 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Base Study P05788 - Assigned Treatment | Spontaneous pregnancy | 0 | 1 | 0 | 0 |
| Base Study P05788 - Embryo Transfer | No embryo transfer | 3 | 6 | 0 | 0 |
| Base Study P05788 - Follow-Up | No ongoing pregnancy at 10 weeks | 15 | 10 | 0 | 0 |
Baseline characteristics
| Characteristic | Expectant Mothers Administered Corifollitropin Alpha 100 ug | Expectant Mothers Administered Corifollitropin Alpha 150 ug | Total |
|---|---|---|---|
| Age, Continuous | 30.1 Years STANDARD_DEVIATION 2 | 31.3 Years STANDARD_DEVIATION 4.2 | 30.7 Years STANDARD_DEVIATION 3.3 |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 7 | 6 / 8 | 5 / 8 | 11 / 11 |
| serious Total, serious adverse events | 2 / 7 | 2 / 8 | 6 / 8 | 7 / 11 |
Outcome results
Primary
Number of Expectant Mothers Experiencing Adverse Events (AEs)
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.
Time frame: Up to 1 Year
Population: Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Expectant Mothers Administered Corifollitropin Alpha 100 ug | Number of Expectant Mothers Experiencing Adverse Events (AEs) | 7 Participants |
| Expectant Mothers Administered Corifollitropin Alpha 150 ug | Number of Expectant Mothers Experiencing Adverse Events (AEs) | 6 Participants |
Primary
Number of Expectant Mothers Experiencing Serious AEs (SAEs)
An AE or suspected adverse reaction is considered serious if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Time frame: Up to 1 Year
Population: Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Expectant Mothers Administered Corifollitropin Alpha 100 ug | Number of Expectant Mothers Experiencing Serious AEs (SAEs) | 2 Participants |
| Expectant Mothers Administered Corifollitropin Alpha 150 ug | Number of Expectant Mothers Experiencing Serious AEs (SAEs) | 2 Participants |
Primary
Number of Infants Experiencing AEs
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.
Time frame: Up to 1 Year
Population: Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Expectant Mothers Administered Corifollitropin Alpha 100 ug | Number of Infants Experiencing AEs | 6 Participants |
| Expectant Mothers Administered Corifollitropin Alpha 150 ug | Number of Infants Experiencing AEs | 11 Participants |
Primary
Number of Infants Experiencing SAEs
An AE or suspected adverse reaction is considered serious if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Time frame: Up to 1 Year
Population: Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Expectant Mothers Administered Corifollitropin Alpha 100 ug | Number of Infants Experiencing SAEs | 6 Participants |
| Expectant Mothers Administered Corifollitropin Alpha 150 ug | Number of Infants Experiencing SAEs | 7 Participants |
Primary
Take-Home Baby Rate
The take-home baby rate was calculated as the number of participants with a least one live born infant in the follow-up study (P05783, 38834, NCT00702520) relative to the number of participants treated with Corifollitropin alpha in the base study (P05788, 38833, NCT00702351).
Time frame: Birth of a one or more live babies (Up to 1 year)
Population: Participants treated with Corifollitropin alpha in the base study (P05788, 38833).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Expectant Mothers Administered Corifollitropin Alpha 100 ug | Take-Home Baby Rate | 28.0 Percentage of participants |
| Expectant Mothers Administered Corifollitropin Alpha 150 ug | Take-Home Baby Rate | 33.3 Percentage of participants |