Primary outcomeMean· At the end of stimulation (Day 2 up to Day 8)
Number of Oocytes Retrieved
| Group | Value (Oocytes) | Spread |
|---|---|---|
| r-FSH + r-hLH | 4.0 | 5.3 |
| r-FSH | 3.5 | 3.1 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataLutropin Alfa in Women at Risk of Poor Response
NCTNCT01112358 (opens ClinicalTrials.gov in a new tab)Other idIMP26170 (INI25954)Other id2005-002229-30Other id2005
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 58 participants (actual)
- Sponsor
- Merck KGaA, Darmstadt, Germany · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
Spain
- Start
- 7 Dec 2005
- Primary completion
- 30 Jan 2007
- Completion
- 30 Jan 2007
- First posted
- 28 Apr 2010 (estimated)
- Last update posted
- 28 Aug 2018
- Conditions
- Ovarian Stimulation
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2005200620072008
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Evaluate the effectiveness of adding lutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) in the middle of the follicular phase compared to no addition, in infertile women at risk of poor response stimulated with follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) under Gonadotropin Releasing Hormone (GnRH) antagonist in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI), in the number and quality of oocytes, follicular development, fertilization oocyte, embryo quality, and pregnancy rate.
Interventions
- r-FSHDrug
- r-hLHDrug
- Analogous GnRH antagonistDrug
- r-hCGDrug
- ProgesteroneDrug
Arms2
Experimental
r-FSH + r-hLH
Lutropin alfa (r-hLH) will be administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (r-FSH) will be administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose will then be adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants will also receive analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) will be administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist.
Active comparator
r-FSH
Follitropin alfa (r-FSH) will be administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose will then be adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants will also receive analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG will be administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist.
Primary outcomes3
Outcomes the sponsor listed as primary.
Number of Oocytes Retrieved
Time frame · At the end of stimulation (Day 2 up to Day 8)
Number of Follicles Greater Than (>) 14 Millimeter (mm) in Diameter
Time frame · At the end of stimulation (Day 2 up to Day 8)
Oocytes Recovery Rate
Time frame · At the end of stimulation (Day 2 up to Day 8)
Registry description
Oocytes recovery rate (oocytes per \>14 mm follicle) is defined as number of oocytes retrieved divided by number of follicles \>14 mm in diameter.
Secondary outcomes(13)
Oocyte Nuclear Maturity Rate
Time frame · At the end of stimulation (Day 2 up to Day 8)
Registry description
Oocyte nuclear maturity rate (metaphase II oocytes per retrieved oocyte) is defined as number of metaphase II oocytes divided by total number of oocytes retrieved.
Fertilization Rate
Time frame · Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)
Registry description
The fertilization rate (2 pronuclei \[PN\] fertilized oocytes per inseminated oocyte) was defined as number of 2 PN fertilized oocytes divided by number of inseminated oocytes.
Number of Embryos by Quality
Time frame · Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)
Registry description
Embryo quality was graded according to morphological classification of Veeck. Grade 1: even blastomeres with no fragmentation; Grade 2: even blastomeres with slight fragmentation (less than 20%); Grade 3: uneven size blastomeres with no fragmentation; Grade 4: even or uneven size blastomeres with moderate fragmentation (20-25%); and Grade 5: unrecognizable blastomeres with severe fragmentation (\>50%).
Number of Embryos Transferred by In Vitro Fertilization (IVF)
Time frame · Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)
Number of Participants With Positive Pregnancy Test
Time frame · Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)
Registry description
The beta Human Chorionic Gonadotropin (beta-hCG) test was used as pregnancy test.
Number of Participants With Clinical Pregnancy
Time frame · Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)
Registry description
A clinical pregnancy is a pregnancy that is confirmed by both pregnancy test (beta-hCG test) and sonographic confirmation of a gestational sac or heartbeat (fetal sac).
Implementation Rate
Time frame · Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)
Registry description
Implementation rate (clinical pregnancy/embryo transferred) was defined as the number of clinical pregnancies divided by number of embryos transferred.
Plasma Level of Estradiol
Time frame · At the time of r-hCG administration (any days between Day 2 to Day 8)
Endometrial Thickness
Time frame · At the time of r-hCG administration (any days between Day 2 to Day 8)
Duration of Ovarian Stimulation
Time frame · Randomization to Day 8
Registry description
Duration of ovarian stimulation was defined as the time from start of study treatment to time of r-hCG administration.
rFSH Cumulative Dose
Time frame · Randomization to Day 8
Plasma Levels of LH
Time frame · At the time of r-hCG administration (any days between Day 2 to Day 8)
Number of Participants in Whom At Least 1 Stimulation Cycle Was Cancelled
Time frame · Randomization to Day 8
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· At the end of stimulation (Day 2 up to Day 8)
Number of Follicles Greater Than (>) 14 Millimeter (mm) in Diameter
| Group | Value (Follicles) | Spread |
|---|---|---|
| r-FSH + r-hLH | 7.2 | 1.1 |
| r-FSH | 7.0 | 0.8 |
Primary outcomeMean· At the end of stimulation (Day 2 up to Day 8)
Oocytes Recovery Rate
| Group | Value (oocytes per >14 mm follicle) | Spread |
|---|---|---|
| r-FSH + r-hLH | 0.56 | 0.42 |
| r-FSH | 0.50 | 0.41 |
Secondary and other outcome results(5)
Secondary outcomeMean· At the end of stimulation (Day 2 up to Day 8)
Oocyte Nuclear Maturity Rate
| Group | Value (metaphase II oocytes/retrieved oocyte) | Spread |
|---|---|---|
| r-FSH + r-hLH | 0.73 | 0.75 |
| r-FSH | 0.61 | 0.26 |
Secondary outcomeMean· Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)
Fertilization Rate
| Group | Value (2PN fertilized oocyte/inseminated oocyte) | Spread |
|---|---|---|
| r-FSH + r-hLH | 0.70 | 0.35 |
| r-FSH | 0.64 | 0.33 |
Secondary outcomeMean· Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)
Number of Embryos by Quality
| Group | Value (Embroys) | Spread |
|---|---|---|
| r-FSH + r-hLH | 0.6 | 0.7 |
| r-FSH | 0.8 | 1.0 |
Secondary outcomeMean· Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)
Number of Embryos Transferred by In Vitro Fertilization (IVF)
| Group | Value (Embroys) | Spread |
|---|---|---|
| r-FSH + r-hLH | 2.0 | 1.0 |
| r-FSH | 1.6 | 0.8 |
Secondary outcomeNumber· Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)
Number of Participants With Positive Pregnancy Test
| Group | Value (Participants) |
|---|---|
| r-FSH + r-hLH | 3 |
| r-FSH | 5 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| r-FSH + r-hLHLutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8). | – | 0 / 25 | 0 / 25 |
| r-FSHFollitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8). | – | 0 / 33 | 0 / 33 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- ResultM.J. Fernández Ramírez, A. Monzó, T. García-Gimeno, J.M. Rubio, V. Montañana, C. Duque, G. Herrero, A. Romeu. Role of LH administration during the follicullar phase in women with risk of low response in ovarian stimulation with FSH and cetrorelix for IVF, REVISTA IBEROAMERICANA DE FERTILIDAD, Vol. 23- nº 5 - Septiembre-Octubre 2006
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- up to 38 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Participants who were at risk of poor response by at least one of the following criteria: a) \<3 follicles in last cycle, or less than or equal to (\</=) 2 metaphase II oocytes, or estradiol (E2) \<600 pg/mL; b) Cancellation of previous cycle; c) Early follicular serum Follicle-Stimulating Hormone (FSH) \>8.5 milli IU/L
* Participants with normal baseline luteinizing hormone and E2 levels
* Regular menstrual cycles of 25-35 days
* Presence of both ovaries and uterus able to withstand pregnancy
Exclusion Criteria:
* Participants who had any clinically significant disease including known human immunodeficiency virus (HIV), hepatitis-B virus (HBV)/hepatitis-C virus (HCV) positivity
* Participants with more than 3 previous assisted reproductive techniques (ART) cycles
* Participants with polycystic ovaries or cyst of unknown etiology; unexplained gynecological bleeding
* Participants who had any contraindication to being pregnant
* Active substance abuse
* Participants who had simultaneously participated in another clinical drug trial
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