Phase 3
Completed N=682
Corifollitropin Alfa in Participants Undergoing Repeated Controlled Ovarian Stimulation (COS) Cycles Using a Multiple Dose Gonadatropin Releasing Hormone (GnRH) Antagonist Protocol (Study 38825)(P05714)
In Vitro Fertilization
Source: ClinicalTrials.gov NCT00696878 ↗
Enrolled (actual)
682
Serious AEs
7.5%
Results posted
Apr 2015
Primary outcomePrimary: Percentage of Participants With Clinically Relevant Immunogenicity — 0.0; 0.0; 0.0 percentage of participants
Summary
The objective of the trial is to assess the non-immunogenicity and safety of corifollitropin alfa (also known as Org 36286, SCH 900962 and MK-8962) in participants undergoing repeated COS cycles using a multiple dose GnRH antagonist protocol.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Clinically Relevant Immunogenicity |
0.0; 0.0; 0.0 | — |
| PRIMARY Local Tolerance at Injection Site: Number of Participants With no Event of Itching and With Mild, Moderate and Severe Itching in Any of 3 Treatment Cycles |
679; 3; 0; 0 | — |
| PRIMARY Local Tolerance at Injection Site: Number of Participants With no Event of Pain and With Mild, Moderate and Severe Pain in Any of 3 Treatment Cycles |
678; 4; 0; 0 | — |
| PRIMARY Local Tolerance at Injection Site: Number of Participants With no Event of Redness and With Mild, Moderate and Severe Redness in Any of 3 Treatment Cycles |
654; 28; 0; 0 | — |
| PRIMARY Local Tolerance at Injection Site: Number of Participants With no Event of Swelling and With Mild, Moderate and Severe Swelling in Any of 3 Treatment Cycles |
680; 2; 0; 0 | — |
| PRIMARY Local Tolerance at Injection Site Overall Summary: Number of Participants With no Local Tolerance Event (Itching, Pain, Redness or Swelling) and With a Mild, Moderate and Severe Local Tolerance Event in Any of 3 Treatment Cycles |
647; 35; 0; 0 | — |
| PRIMARY Number of Participants With AEs |
409 | — |
| PRIMARY Number of Participants With Serious AEs (SAEs) |
51 | — |
| PRIMARY Number of Participants With Moderate to Severe Ovarian Hyperstimulation Syndrome (OHSS) |
12; 4; 0 | — |
| SECONDARY Amount of (Rec)FSH Needed From Stimulation Day 8 Onwards to Reach the Criterion for Administration of (Rec)hCG |
400.0; 450.0; 450.0 | — |
| SECONDARY Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 1 |
0.0; 0.0; 0.0 | — |
| SECONDARY Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 2 |
0.0; 0.0; 0.0 | — |
| SECONDARY Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 3 |
0.0; 0.0; 0.0 | — |
| SECONDARY Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 1 |
5.1; 0.4; 0.1 | — |
| SECONDARY Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 2 |
4.8; 0.4; 0.1 | — |
| SECONDARY Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 3 |
4.0; 0.3; 0.0 | — |
| SECONDARY Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 1 |
11.1; 3.7; 1.1 | — |
| SECONDARY Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 2 |
10.7; 3.6; 1.2 | — |
| SECONDARY Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 3 |
10.0; 3.4; 1.1 | — |
| SECONDARY Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 1 |
14.5; 9.2; 5.4 | — |
| SECONDARY Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 2 |
13.9; 9.0; 5.4 | — |
| SECONDARY Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 3 |
13.7; 9.0; 5.4 | — |
| SECONDARY Number of Oocytes Retrieved in a Participant Among Entire Study Population |
11.9; 11.5; 11.3 | — |
| SECONDARY Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 1 |
12.2; 0.8; 9.8; 0.9 | — |
| SECONDARY Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 2 |
11.6; 0.9; 9.3; 0.8 | — |
| SECONDARY Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 3 |
11.3; 0.8; 9.1; 0.9 | — |
| SECONDARY Number of Fertilized Oocytes Obtained in Treatment Cycle 1 |
2.2; 0.2; 6.1; 0.3; 0.7 | — |
| SECONDARY Number of Fertilized Oocytes Obtained in Treatment Cycle 2 |
2.1; 0.3; 6.1; 0.3; 0.6 | — |
| SECONDARY Number of Fertilized Oocytes Obtained in Treatment Cycle 3 |
1.8; 0.2; 6.2; 0.3; 0.8 | — |
| SECONDARY Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 1 |
0.0; 0.0; 1.9; 0.0; 0.0 | — |
| SECONDARY Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 2 |
0.0; 0.0; 1.6; 0.0; 0.0 | — |
| SECONDARY Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 3 |
0.0; 0.0; 1.1; 0.0; 0.0 | — |
| SECONDARY Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 1 |
0.6; 0.1; 5.7; 0.0; 0.0 | — |
| SECONDARY Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 2 |
0.6; 0.1; 5.8; 0.0; 0.0 | — |
| SECONDARY Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 3 |
0.5; 0.1; 6.0; 0.0; 0.1 | — |
| SECONDARY Fertilization Rate |
67.0; 66.0; 67.3 | — |
| SECONDARY Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 1 |
6.4; 3.2; 1.2; 1.9; 2.3; 1.0 | — |
| SECONDARY Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 2 |
6.5; 2.9; 1.2; 1.8; 2.4; 1.2 | — |
| SECONDARY Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 3 |
6.6; 2.8; 1.0; 1.8; 2.6; 1.1 | — |
| SECONDARY Number of Embryos Transferred |
1.9; 2.1; 2.2 | — |
| SECONDARY Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 1 |
110; 230; 201; 75 | — |
| SECONDARY Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 2 |
81; 80; 122; 57 | — |
| SECONDARY Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 3 |
31; 49; 65; 33 | — |
| SECONDARY Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 1 |
1.6; 1.2; 0.4; 0.8; 0.4; 0.1 | — |
| SECONDARY Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 2 |
1.1; 0.8; 0.3; 0.5; 0.3; 0.0 | — |
| SECONDARY Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 3 |
1.1; 0.8; 0.3; 0.5; 0.3; 0.0 | — |
| SECONDARY Implantation Rate for Participants With ET |
21.2; 16.6; 16.3 | — |
| SECONDARY Number of Participants With Biochemical Pregnancy, Clinical Pregnancy, Vital Pregnancy and Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3 |
340; 303; 278; 272 | — |
| SECONDARY Number of Participants With Singleton and Multiple Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3 |
226; 46 | — |
| SECONDARY Number of Participants With Miscarriage Among Participants With Clinical Pregnancy in Any of Treatment Cycles 1, 2 or 3 |
37 | — |
| SECONDARY Number of Participants With Miscarriage Among Participants With Vital Pregnancy in Any of Treatment Cycles 1, 2 or 3 |
5 | — |
| SECONDARY Number of Participants With Ectopic Pregnancy Among Participants With Biochemical Pregnancy in Any of Treatment Cycles 1, 2 or 3 |
9 | — |
| SECONDARY Number of Participants With Ongoing Pregnancy in Any FTET Cycle |
48 | — |
| SECONDARY Cumulative Ongoing Pregnancy Rate: Percentage of Participants With Ongoing Pregnancy in Treatment Cycles 1, 2 or 3, or in Any FTET Cycle, or Who Had Ongoing Pregnancy That Was a Spontaneous Pregnancy |
50.6 | — |
| SECONDARY Serum Follicle Stimulating Hormone (FSH) Levels in Treatment Cycle 1 |
7.18; 24.00; 13.23; 13.63; 3.21; 4.84 | — |
| SECONDARY Serum FSH Levels in Treatment Cycle 2 |
7.17; 24.24; 13.38; 13.78; 3.20; 5.07 | — |
| SECONDARY Serum FSH Levels in Treatment Cycle 3 |
7.50; 24.51; 13.56; 13.62; 3.17; 5.01 | — |
| SECONDARY Serum Luteinizing Hormone (LH) Levels in Treatment Cycle 1 |
5.07; 4.86; 1.34; 1.53; NA; 3.27 | — |
| SECONDARY Serum LH Levels in Treatment Cycle 2 |
5.13; 4.78; 1.35; 1.67; NA; 3.41 | — |
| SECONDARY Serum LH Levels in Treatment Cycle 3 |
5.05; 4.84; 1.36; 1.79; NA; 3.57 | — |
| SECONDARY Serum Estradiol Levels in Treatment Cycle 1 |
126.07; 2246.72; 3224.72; 5602.90; 2972.22; 1064.92 | — |
| SECONDARY Serum Estradiol Levels in Treatment Cycle 2 |
120.80; 2116.13; 3197.12; 5444.89; 2988.11; 929.24 | — |
| SECONDARY Serum Estradiol Levels in Treatment Cycle 3 |
117.5; 1993.66; 3164.08; 5605.89; 3065.47; 746.52 | — |
| SECONDARY Serum Progesterone Levels in Treatment Cycle 1 |
1.99; 2.72; 1.85; 4.14; 331.16; 100.31 | — |
| SECONDARY Serum Progesterone Levels in Treatment Cycle 2 |
1.84; 2.14; 1.75; 3.91; 316.28; 88.21 | — |
| SECONDARY Serum Progesterone Levels in Treatment Cycle 3 |
1.76; 2.29; 1.75; 4.92; 311.64; 79.03 | — |
| SECONDARY Serum Inhibin-B Levels in Treatment Cycle 1 |
48.22; 409.63; 455.46; 523.07; NA; NA | — |
| SECONDARY Serum Inhibin-B Levels in Treatment Cycle 2 |
48.88; 406.29; 443.32; 505.02; 29.38; 39.04 | — |
| SECONDARY Serum Inhibin-B Levels in Treatment Cycle 3 |
50.49; 406.14; 439.83; 504.03; 26.28; 40.16 | — |
Eligibility Criteria
Inclusion Criteria
- Females of couples with an indication for COS and IVF or ICSI;
- >=18 and 60 kg and body mass index (BMI) >=18 and 10 mm (visible on USS);
- Presence of unilateral or bilateral hydrosalpinx (visible on USS);
- More than three unsuccessful COS cycles since the last established ongoing pregnancy (if applicable);
- History of non- or low ovarian response to FSH/human menopausal gonadotrophin (hMG) treatment;
- FSH > 12 IU/L or luteinizing hormone (LH) > 12 IU/L as measured by the local laboratory (sample taken during the early follicular phase: menstrual cycle day 2-5);
- Any clinically relevant abnormal laboratory value based on a sample taken during the screening phase, including abnormal cervical smear (Papanicolaou [PAP]>=III, cervical intraepithelial neoplasia [CIN]>=1);
- Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts) or GnRH antagonists (e.g. hypersensitivity, pregnancy/lactation);
- Recent history of or current epilepsy, human immunodeficiency virus (HIV) infection, thrombophilia, diabetes or cardiovascular, gastro-intestinal, hepatic, renal, or pulmonary disease;
- Abnormal karyotyping of the participant or her partner (if karyotyping is performed);
- History or presence of alcohol or drug abuse within 12 months prior to signing informed consent;
- Previous use of corifollitropin alfa;
- Use of hormonal preparations within 1 month prior to screening;
- Administration of investigational drugs within three months prior to signing informed consent.
Data sourced from ClinicalTrials.gov (NCT00696878). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.